This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

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Resource Profile: M11Report

Profile of Composition for Evidence Based Medicine IG. The M11Report Profile is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.

Usage:

• Examples for this Resource Profile: Composition/181448

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from EvidenceReport

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
Slices for category		1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text
category:m11report	S	1..1	CodeableConcept	Categorization of Composition
text		1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
Slices for section		15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:summary	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1-protocol-summary
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1-protocol-synopsis
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1.1-objectives-endpoints
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Composition)	A reference to data that supports this section
section:overallDesign		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1.2-overall-design
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
section:numberOfArms		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Number of Arms
text		1..1	Narrative	Text summary of the section, for human interpretation
section:blinding		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Blinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:numberOfParticipants		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Number of Participants
text		1..1	Narrative	Text summary of the section, for human interpretation
section:duration		0..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Arms and Duration
text		1..1	Narrative	Text summary of the section, for human interpretation
section:committees		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Committees
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialSchema	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.2-trial-schema
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.3-schedule-of-activities
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:introduction	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2-introduction
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.1-trial-purpose
text		1..1	Narrative	Text summary of the section, for human interpretation
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2-benefits-risks
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.1-benefit-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:riskSummary		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2-risk-summary
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.1-trial-intervention-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialProcedures		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.2-trial-procedures-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherRisk		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.3-trial-other-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.3-overall-benefit-risk-conclusion
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoints	S	1..*	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
code
text		1..1	string	Plain text representation of the concept Required Pattern: section3-endpoints
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section3.1-objective-endpoint-estimand
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
code
text		1..1	string	Plain text representation of the concept Required Pattern: Primary/Secondary/Exploratory
text		1..1	Narrative	Text summary of the section, for human interpretation
section:objective	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: Objective
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoint	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
code
text		1..1	string	Plain text representation of the concept Required Pattern: Endpoint
text		1..1	Narrative	Text summary of the section, for human interpretation
section:estimand	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: Estimand
text		1..1	Narrative	Text summary of the section, for human interpretation
section:design	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4-trial-design
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.1-description-of-trial-design
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.1.1-stakeholder-input-into-design
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rationale	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2-rationale-for-trial-design
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.1-rationale-intervention-model
text		1..1	Narrative	Text summary of the section, for human interpretation
section:duration	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.2-rationale-duration
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoints	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.3-rationale-endpoints
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interim	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.4-rationale-interim-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:comparator	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.5-rationale-comparator
text		1..1	Narrative	Text summary of the section, for human interpretation
section:adaptive	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.6-rationale-adaptive
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAspects	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.7-rationale-other-aspects
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.3-trial-stopping-rules
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.3.1-temporary-trial-halt
text		1..1	Narrative	Text summary of the section, for human interpretation
section:startEnd	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.4-start-and-end
text		1..1	Narrative	Text summary of the section, for human interpretation
section:access	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.5-access-after-trial
text		1..1	Narrative	Text summary of the section, for human interpretation
section:population	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5-trial-population
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.1-population-description
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.2-inclusion-criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.3-exclusion-criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:lifestyle	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4-lifestyle-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.1-dietary-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:substances	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.2-substances-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:activity	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.3-activity-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:other	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.4-other-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:screenFailures	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.5-screen-failure
text		1..1	Narrative	Text summary of the section, for human interpretation
section:intervention	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6-trial-intervention
Slices for section		8..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.1-description-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.2-rationale-for-trial-intervention-regimen
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.3-dosing-and-administration
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition)	A reference to data that supports this section
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.3.1-dose-modification
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition)	A reference to data that supports this section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.4-management-of-overdose
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
section:preparation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5-preparation-storage-handling
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.1-preparation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:storageHandling	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.2-storage-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:accountability	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.3-accountability
text		1..1	Narrative	Text summary of the section, for human interpretation
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6-assignment-randomisation-blinding
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.1-assignment
text		1..1	Narrative	Text summary of the section, for human interpretation
section:randomisation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.2-randomisation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:blinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.3-blinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:unblinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.4-unblinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:compliance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.7-intervention-compliance
text		1..1	Narrative	Text summary of the section, for human interpretation
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8-noninvestigational-interventions
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.1-background-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rescue	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.2-rescue-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:other	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.3-other-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9.1-prohibited-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:permitted	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9.2-permitted-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:dropout	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7-participant-discontinuation
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1-discontinuation-of-trial-intervention
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:temporary	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rechallenge	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.3-rechallenge
text		1..1	Narrative	Text summary of the section, for human interpretation
section:withdrawal	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.2-participant-withdrawal
text		1..1	Narrative	Text summary of the section, for human interpretation
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.3-lost-to-follow-up
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.4-participant-stopping-rules
text		1..1	Narrative	Text summary of the section, for human interpretation
section:assessments	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		8..*		Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.1-screening-baseline-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:efficacy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.2-efficacy-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safety	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3-safety-assessments
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.1-physical-examination
text		1..1	Narrative	Text summary of the section, for human interpretation
section:vitals	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.2-vital-signs
text		1..1	Narrative	Text summary of the section, for human interpretation
section:ecg	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.3-electrocardiograms
text		1..1	Narrative	Text summary of the section, for human interpretation
section:laboratory	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.4-clinical-laboratory-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnancy	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.5-pregnancy-testing
text		1..1	Narrative	Text summary of the section, for human interpretation
section:suicidal	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.6-suicidal-ideation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4-pharmacokinetics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:genetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.5-genetic-testing
text		1..1	Narrative	Text summary of the section, for human interpretation
section:biomarkers	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6-biomarkers
text		1..1	Narrative	Text summary of the section, for human interpretation
section:immunogenicity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.7-immunogenicity-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:economics	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.8-economics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:adverseEvents	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9-adverse-events
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1-definitions
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.1-definitions-adverse-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.2-definitions-serious-adverse-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.3-definitions-product-complaints
text		1..1	Narrative	Text summary of the section, for human interpretation
section:collectionMethods	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.2-collection-methods
text		1..1	Narrative	Text summary of the section, for human interpretation
section:recording	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3-recording-and-follow-up
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.1-identifying-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:intensity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.2-intensity
text		1..1	Narrative	Text summary of the section, for human interpretation
section:causality	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.3-causality
text		1..1	Narrative	Text summary of the section, for human interpretation
section:recordingEvents	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.4-recording-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:followup	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.5-followup
text		1..1	Narrative	Text summary of the section, for human interpretation
section:reporting	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4-reporting-events
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.1-reporting-serious-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.2-regulatory-requirements
text		1..1	Narrative	Text summary of the section, for human interpretation
section:specialInterest	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.3-special-interest
text		1..1	Narrative	Text summary of the section, for human interpretation
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.4-disease-related-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnancy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5-collection-methods
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5.1-pregnant
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5.2-pregnant-partner
text		1..1	Narrative	Text summary of the section, for human interpretation
section:statistics	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.1-analysis-sets
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-primary-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3-analysis-secondary-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-exploratory-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5-safety-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.6-other-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.7-interim-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sampleSize	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.8-sample-size-determination
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.9-protocol-deviations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:oversight	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11-oversight
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.1-regulatory-considerations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialOversight	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2-trial-oversight
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2.1-investigator-responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2.2-sponsor-responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:committees	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.3-committees
text		1..1	Narrative	Text summary of the section, for human interpretation
section:informedConsent	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4-informed-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-assent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:emergency	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-emergency-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rescreening	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.1-rescreening-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:remainingSamples	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.2-remaining-samples
text		1..1	Narrative	Text summary of the section, for human interpretation
section:insurance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.5-insurance-and-indemnity
text		1..1	Narrative	Text summary of the section, for human interpretation
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#decisionRights
text		1..1	Narrative	Text summary of the section, for human interpretation
section:criteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
section:responsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:riskManagementAndData	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12-risk-management-and-data-governance
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.1-risk-management
text		1..1	Narrative	Text summary of the section, for human interpretation
section:dataGovernance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.2-data-governance
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sourceData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.3-source-data
text		1..1	Narrative	Text summary of the section, for human interpretation
section:definitions	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13-definitions
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1-contraception
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1.1-contraception-definitions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1.2-contraception-details
text		1..1	Narrative	Text summary of the section, for human interpretation
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.2-clinical-laboratory-tests
text		1..1	Narrative	Text summary of the section, for human interpretation
section:regional	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.3-country-specific-differences
text		1..1	Narrative	Text summary of the section, for human interpretation
section:priorAmendments	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.4-prior-protocol-amendments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:glossary	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section14-glossary
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
section:references	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
code
text		1..1	string	Plain text representation of the concept Required Pattern: section15-references
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Citation)	A reference to data that supports this section
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
versionAlgorithm		0..1	string	How to compare versions URL: http://hl7.org/fhir/StructureDefinition/artifact-version profiled by http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
experimental		0..1	boolean	For testing purposes, not real usage URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
description		0..1	markdown	Natural language description of the {{title}} URL: http://hl7.org/fhir/StructureDefinition/artifact-description
purpose		0..1	markdown	Why this {{title}} is defined URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
copyright		0..1	markdown	Use and/or publishing restrictions URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
copyrightLabel		0..1	string	Copyright holder and year(s) URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
approvalDate		0..1	date	When the resource was approved by publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-approvalDate
lastReviewDate		0..1	date	When the resource was last reviewed by the publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-lastReviewDate
effectivePeriod		0..1	Period	When the resource is expected to be used URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-effectivePeriod
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://fevir.net/resources/CodeSystem/179423
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EvidenceReport
display		1..1	string	Representation defined by the system Fixed Value: EvidenceReport
Slices for category	Σ	1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
category:m11report	SΣ	1..1	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
subject	Σ	0..1	Reference(Citation | Classification | EvidenceReportSubject | ResearchStudy)	Who and/or what the composition is about
date	Σ	1..1	dateTime	Composition editing time
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	Σ	1..1	string	Human Readable name/title
Slices for section	C	15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:summary	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Composition)	A reference to data that supports this section
section:overallDesign		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
section:numberOfArms		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:blinding		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:numberOfParticipants		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:duration		0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:committees		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialSchema	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:introduction	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:riskSummary		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialProcedures		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherRisk		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoints	SC	1..*	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:objective	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoint	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:estimand	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:design	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:duration	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoints	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interim	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:comparator	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:adaptive	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAspects	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:startEnd	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:access	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:population	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:lifestyle	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:substances	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:activity	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:other	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:screenFailures	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:intervention	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
section:preparation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:storageHandling	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:accountability	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:randomisation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:blinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:unblinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:compliance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rescue	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:other	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:permitted	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:dropout	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:temporary	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rechallenge	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:withdrawal	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:assessments	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
text	C	0..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:efficacy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safety	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:vitals	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:ecg	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:laboratory	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnancy	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:suicidal	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:genetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:biomarkers	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:immunogenicity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:economics	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:adverseEvents	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:collectionMethods	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:recording	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:intensity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:causality	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:recordingEvents	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:followup	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:reporting	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:specialInterest	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnancy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statistics	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sampleSize	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:oversight	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialOversight	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
text	C	0..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:committees	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:informedConsent	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:emergency	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rescreening	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:remainingSamples	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:insurance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:criteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:responsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:riskManagementAndData	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:dataGovernance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sourceData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:definitions	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:regional	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:priorAmendments	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:glossary	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
section:references	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Citation)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.category:m11report	example	ReferencedItemCategoryValueSet

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
versionAlgorithm		0..1	string	How to compare versions URL: http://hl7.org/fhir/StructureDefinition/artifact-version profiled by http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
experimental		0..1	boolean	For testing purposes, not real usage URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
description		0..1	markdown	Natural language description of the {{title}} URL: http://hl7.org/fhir/StructureDefinition/artifact-description
purpose		0..1	markdown	Why this {{title}} is defined URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
copyright		0..1	markdown	Use and/or publishing restrictions URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
copyrightLabel		0..1	string	Copyright holder and year(s) URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
approvalDate		0..1	date	When the resource was approved by publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-approvalDate
lastReviewDate		0..1	date	When the resource was last reviewed by the publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-lastReviewDate
effectivePeriod		0..1	Period	When the resource is expected to be used URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-effectivePeriod
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://fevir.net/resources/CodeSystem/179423
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EvidenceReport
display		1..1	string	Representation defined by the system Fixed Value: EvidenceReport
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for category	Σ	1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
category:m11report	SΣ	1..1	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
subject	Σ	0..1	Reference(Citation | Classification | EvidenceReportSubject | ResearchStudy)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	Σ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
mode		1..1	CodeableConcept	reviewer | editor | endorser | informant Binding: ContributorRole (preferred)
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	C	15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:summary	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1-protocol-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1-protocol-synopsis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1.1-objectives-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Composition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:overallDesign		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1.2-overall-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:numberOfArms		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Number of Arms
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:blinding		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:numberOfParticipants		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Number of Participants
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:duration		0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Arms and Duration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:committees		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Committees
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialSchema	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.2-trial-schema
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.3-schedule-of-activities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:introduction	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2-introduction
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.1-trial-purpose
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2-benefits-risks
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.1-benefit-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:riskSummary		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.1-trial-intervention-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialProcedures		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.2-trial-procedures-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherRisk		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.3-trial-other-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.3-overall-benefit-risk-conclusion
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoints	SC	1..*	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section3-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section3.1-objective-endpoint-estimand
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Primary/Secondary/Exploratory
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:objective	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoint	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Endpoint
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:estimand	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Estimand
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:design	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.1-description-of-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.1.1-stakeholder-input-into-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rationale	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2-rationale-for-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.1-rationale-intervention-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:duration	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.2-rationale-duration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoints	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.3-rationale-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interim	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.4-rationale-interim-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:comparator	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.5-rationale-comparator
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:adaptive	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.6-rationale-adaptive
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAspects	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.7-rationale-other-aspects
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.3-trial-stopping-rules
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.3.1-temporary-trial-halt
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:startEnd	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.4-start-and-end
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:access	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.5-access-after-trial
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:population	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5-trial-population
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.1-population-description
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.2-inclusion-criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.3-exclusion-criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:lifestyle	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4-lifestyle-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.1-dietary-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:substances	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.2-substances-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:activity	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.3-activity-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:other	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.4-other-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:screenFailures	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.5-screen-failure
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intervention	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.1-description-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rationale	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.2-rationale-for-trial-intervention-regimen
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.3-dosing-and-administration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.3.1-dose-modification
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.4-management-of-overdose
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:preparation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5-preparation-storage-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.1-preparation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:storageHandling	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.2-storage-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:accountability	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.3-accountability
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6-assignment-randomisation-blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.1-assignment
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:randomisation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.2-randomisation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:blinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.3-blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:unblinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.4-unblinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:compliance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.7-intervention-compliance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8-noninvestigational-interventions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.1-background-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rescue	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.2-rescue-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:other	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.3-other-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9.1-prohibited-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:permitted	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9.2-permitted-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dropout	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7-participant-discontinuation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:temporary	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rechallenge	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.3-rechallenge
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:withdrawal	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.2-participant-withdrawal
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.3-lost-to-follow-up
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.4-participant-stopping-rules
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:assessments	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.1-screening-baseline-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:efficacy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.2-efficacy-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safety	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3-safety-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.1-physical-examination
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:vitals	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.2-vital-signs
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ecg	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.3-electrocardiograms
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:laboratory	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.4-clinical-laboratory-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnancy	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.5-pregnancy-testing
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:suicidal	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.6-suicidal-ideation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.4-pharmacokinetics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:genetics	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.5-genetic-testing
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:biomarkers	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.6-biomarkers
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:immunogenicity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.7-immunogenicity-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:economics	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.8-economics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:adverseEvents	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.1-definitions-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.2-definitions-serious-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.3-definitions-product-complaints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:collectionMethods	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.2-collection-methods
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:recording	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3-recording-and-follow-up
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.1-identifying-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intensity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.2-intensity
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:causality	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.3-causality
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:recordingEvents	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.4-recording-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:followup	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.5-followup
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:reporting	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4-reporting-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.1-reporting-serious-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.2-regulatory-requirements
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:specialInterest	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.3-special-interest
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.4-disease-related-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnancy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5-collection-methods
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5.1-pregnant
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5.2-pregnant-partner
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statistics	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.1-analysis-sets
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-primary-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3-analysis-secondary-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-exploratory-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.5-safety-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.6-other-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.7-interim-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sampleSize	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.8-sample-size-determination
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.9-protocol-deviations
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:oversight	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11-oversight
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.1-regulatory-considerations
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialOversight	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2-trial-oversight
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2.1-investigator-responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2.2-sponsor-responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:committees	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.3-committees
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:informedConsent	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4-informed-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-assent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:emergency	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-emergency-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rescreening	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.1-rescreening-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:remainingSamples	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.2-remaining-samples
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:insurance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.5-insurance-and-indemnity
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#decisionRights
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:criteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:responsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:riskManagementAndData	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12-risk-management-and-data-governance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.1-risk-management
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dataGovernance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.2-data-governance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sourceData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.3-source-data
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:definitions	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1-contraception
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1.1-contraception-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1.2-contraception-details
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.2-clinical-laboratory-tests
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:regional	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.3-country-specific-differences
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:priorAmendments	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.4-prior-protocol-amendments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:glossary	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section14-glossary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:references	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section15-references
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Citation)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.language	required	AllLanguages
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.category:m11report	example	ReferencedItemCategoryValueSet
Composition.attester.mode	preferred	ContributorRole
Composition.event.detail	example	ActCode
Composition.section.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section.orderedBy	preferred	ListOrderCodes
Composition.section.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:summary.orderedBy	preferred	ListOrderCodes
Composition.section:summary.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:overallDesign.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:overallDesign.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:overallDesign.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:blinding.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:blinding.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:blinding.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:duration.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:duration.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:duration.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:committees.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:committees.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:committees.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:trialSchema.code	example	DocumentSectionCodes
Composition.section:summary.section:trialSchema.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:trialSchema.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:scheduleOfActivities.code	example	DocumentSectionCodes
Composition.section:summary.section:scheduleOfActivities.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:scheduleOfActivities.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:introduction.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:purposeOfTrial.code	example	DocumentSectionCodes
Composition.section:introduction.section:purposeOfTrial.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:purposeOfTrial.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:endpoints.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:objective.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:objective.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:objective.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.emptyReason	preferred	ListEmptyReasons
Composition.section:design.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:design.orderedBy	preferred	ListOrderCodes
Composition.section:design.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:description.code	example	DocumentSectionCodes
Composition.section:design.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:description.section:stakeholderInput.code	example	DocumentSectionCodes
Composition.section:design.section:description.section:stakeholderInput.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:description.section:stakeholderInput.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:model.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:model.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:model.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:duration.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:duration.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:duration.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:endpoints.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:endpoints.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:endpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:interim.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:interim.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:interim.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:comparator.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:comparator.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:comparator.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:adaptive.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:adaptive.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:adaptive.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:otherAspects.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:otherAspects.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:otherAspects.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:trialStoppingRules.code	example	DocumentSectionCodes
Composition.section:design.section:trialStoppingRules.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:trialStoppingRules.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code	example	DocumentSectionCodes
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:startEnd.code	example	DocumentSectionCodes
Composition.section:design.section:startEnd.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:startEnd.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:access.code	example	DocumentSectionCodes
Composition.section:design.section:access.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:access.emptyReason	preferred	ListEmptyReasons
Composition.section:population.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:population.orderedBy	preferred	ListOrderCodes
Composition.section:population.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:description.code	example	DocumentSectionCodes
Composition.section:population.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:inclusionCriteria.code	example	DocumentSectionCodes
Composition.section:population.section:inclusionCriteria.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:inclusionCriteria.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:exclusionCriteria.code	example	DocumentSectionCodes
Composition.section:population.section:exclusionCriteria.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:exclusionCriteria.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:dietary.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:dietary.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:dietary.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:substances.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:substances.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:substances.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:activity.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:activity.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:activity.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:other.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:other.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:other.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:screenFailures.code	example	DocumentSectionCodes
Composition.section:population.section:screenFailures.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:screenFailures.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:intervention.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:description.code	example	DocumentSectionCodes
Composition.section:intervention.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:rationale.code	example	DocumentSectionCodes
Composition.section:intervention.section:rationale.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:rationale.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:dosingAdministration.code	example	DocumentSectionCodes
Composition.section:intervention.section:dosingAdministration.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:dosingAdministration.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:dosingAdministration.section:doseModification.code	example	DocumentSectionCodes
Composition.section:intervention.section:dosingAdministration.section:doseModification.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:dosingAdministration.section:doseModification.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:treatmentOfOverdose.code	example	DocumentSectionCodes
Composition.section:intervention.section:treatmentOfOverdose.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:treatmentOfOverdose.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:preparationIntervention.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:preparationIntervention.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:preparationIntervention.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:storageHandling.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:storageHandling.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:storageHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:accountability.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:accountability.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:accountability.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:compliance.code	example	DocumentSectionCodes
Composition.section:intervention.section:compliance.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:compliance.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:background.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:background.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:background.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:other.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:other.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:other.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.section:prohibited.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.section:prohibited.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.section:prohibited.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.section:permitted.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.section:permitted.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.section:permitted.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:dropout.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:permanent.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:permanent.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:permanent.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:temporary.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:temporary.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:temporary.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:rechallenge.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:rechallenge.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:rechallenge.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:withdrawal.code	example	DocumentSectionCodes
Composition.section:dropout.section:withdrawal.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:withdrawal.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:lostToFollowUp.code	example	DocumentSectionCodes
Composition.section:dropout.section:lostToFollowUp.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:lostToFollowUp.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:trialStoppingRules.code	example	DocumentSectionCodes
Composition.section:dropout.section:trialStoppingRules.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:trialStoppingRules.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:assessments.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:screeningBaseline.code	example	DocumentSectionCodes
Composition.section:assessments.section:screeningBaseline.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:screeningBaseline.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:efficacy.code	example	DocumentSectionCodes
Composition.section:assessments.section:efficacy.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:efficacy.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:physical.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:physical.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:physical.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:vitals.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:vitals.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:vitals.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:ecg.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:ecg.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:ecg.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:laboratory.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:laboratory.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:laboratory.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:pregnancy.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:pregnancy.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:pregnancy.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:suicidal.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:suicidal.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:suicidal.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:pharmacokinetics.code	example	DocumentSectionCodes
Composition.section:assessments.section:pharmacokinetics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:pharmacokinetics.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:genetics.code	example	DocumentSectionCodes
Composition.section:assessments.section:genetics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:genetics.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:biomarkers.code	example	DocumentSectionCodes
Composition.section:assessments.section:biomarkers.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:biomarkers.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:immunogenicity.code	example	DocumentSectionCodes
Composition.section:assessments.section:immunogenicity.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:immunogenicity.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:economics.code	example	DocumentSectionCodes
Composition.section:assessments.section:economics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:economics.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:adverseEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:collectionMethods.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:collectionMethods.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:collectionMethods.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:identifying.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:identifying.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:identifying.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:intensity.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:intensity.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:intensity.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:causality.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:causality.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:causality.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:recordingEvents.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:recordingEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:recordingEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:followup.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:followup.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:followup.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:specialInterest.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:specialInterest.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:specialInterest.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.section:pregnant.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnant.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnant.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:statistics.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisSets.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisSets.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisSets.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:safetyAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:safetyAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:safetyAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:otherAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:otherAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:otherAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:interimAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:interimAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:interimAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:sampleSize.code	example	DocumentSectionCodes
Composition.section:statistics.section:sampleSize.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:sampleSize.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:protocolDeviations.code	example	DocumentSectionCodes
Composition.section:statistics.section:protocolDeviations.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:protocolDeviations.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:oversight.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:regulatory.code	example	DocumentSectionCodes
Composition.section:oversight.section:regulatory.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:regulatory.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:committees.code	example	DocumentSectionCodes
Composition.section:oversight.section:committees.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:committees.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:assentProcess.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:assentProcess.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:assentProcess.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:emergency.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:emergency.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:emergency.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:rescreening.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:rescreening.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:rescreening.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:remainingSamples.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:remainingSamples.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:remainingSamples.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:insurance.code	example	DocumentSectionCodes
Composition.section:oversight.section:insurance.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:insurance.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:criteria.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:criteria.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:criteria.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:riskManagementAndData.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:riskManagement.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:riskManagement.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:riskManagement.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:dataGovernance.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:dataGovernance.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:dataGovernance.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:sourceData.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:sourceData.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:sourceData.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:definitions.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.section:contraceptionDetails.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.section:contraceptionDetails.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.section:contraceptionDetails.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:clinicalLaboratoryTests.code	example	DocumentSectionCodes
Composition.section:definitions.section:clinicalLaboratoryTests.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:clinicalLaboratoryTests.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:regional.code	example	DocumentSectionCodes
Composition.section:definitions.section:regional.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:regional.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:priorAmendments.code	example	DocumentSectionCodes
Composition.section:definitions.section:priorAmendments.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:priorAmendments.emptyReason	preferred	ListEmptyReasons
Composition.section:glossary.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:glossary.orderedBy	preferred	ListOrderCodes
Composition.section:glossary.emptyReason	preferred	ListEmptyReasons
Composition.section:references.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:references.orderedBy	preferred	ListOrderCodes
Composition.section:references.emptyReason	preferred	ListEmptyReasons

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from EvidenceReport

Summary

Mandatory: 209 elements (225 nested mandatory elements)
Must-Support: 162 elements

Structures

This structure refers to these other structures:

• SoaPlanDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition)
• VariableDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition)
• CohortDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition)
• ExposureDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition)
• EndpointAnalysisPlan (http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan)

Slices

This structure defines the following Slices:

• The element Composition.category is sliced based on the value of value:text
• The element Composition.section is sliced based on the value of value:code.text
• The element Composition.section.section is sliced based on the value of value:code.text
• The element Composition.section.section.section is sliced based on the value of value:code.text
• The element Composition.section.section.section.section is sliced based on the value of value:code.text

Maturity: 1

Differential View

This structure is derived from EvidenceReport

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
Slices for category		1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text
category:m11report	S	1..1	CodeableConcept	Categorization of Composition
text		1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
Slices for section		15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:summary	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1-protocol-summary
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1-protocol-synopsis
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1.1-objectives-endpoints
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Composition)	A reference to data that supports this section
section:overallDesign		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.1.2-overall-design
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
section:numberOfArms		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Number of Arms
text		1..1	Narrative	Text summary of the section, for human interpretation
section:blinding		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Blinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:numberOfParticipants		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Number of Participants
text		1..1	Narrative	Text summary of the section, for human interpretation
section:duration		0..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Arms and Duration
text		1..1	Narrative	Text summary of the section, for human interpretation
section:committees		1..1	BackboneElement	Nested Section
code
text		1..1	string	Plain text representation of the concept Required Pattern: Committees
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialSchema	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.2-trial-schema
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section1.3-schedule-of-activities
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:introduction	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2-introduction
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.1-trial-purpose
text		1..1	Narrative	Text summary of the section, for human interpretation
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2-benefits-risks
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.1-benefit-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:riskSummary		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2-risk-summary
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.1-trial-intervention-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialProcedures		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.2-trial-procedures-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherRisk		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.3-trial-other-risk-summary
text		1..1	Narrative	Text summary of the section, for human interpretation
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
code
text		1..1	string	Plain text representation of the concept Required Pattern: section2.2.3-overall-benefit-risk-conclusion
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoints	S	1..*	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
code
text		1..1	string	Plain text representation of the concept Required Pattern: section3-endpoints
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section3.1-objective-endpoint-estimand
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
code
text		1..1	string	Plain text representation of the concept Required Pattern: Primary/Secondary/Exploratory
text		1..1	Narrative	Text summary of the section, for human interpretation
section:objective	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: Objective
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoint	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
code
text		1..1	string	Plain text representation of the concept Required Pattern: Endpoint
text		1..1	Narrative	Text summary of the section, for human interpretation
section:estimand	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: Estimand
text		1..1	Narrative	Text summary of the section, for human interpretation
section:design	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4-trial-design
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.1-description-of-trial-design
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.1.1-stakeholder-input-into-design
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rationale	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2-rationale-for-trial-design
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.1-rationale-intervention-model
text		1..1	Narrative	Text summary of the section, for human interpretation
section:duration	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.2-rationale-duration
text		1..1	Narrative	Text summary of the section, for human interpretation
section:endpoints	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.3-rationale-endpoints
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interim	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.4-rationale-interim-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:comparator	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.5-rationale-comparator
text		1..1	Narrative	Text summary of the section, for human interpretation
section:adaptive	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.6-rationale-adaptive
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAspects	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.2.7-rationale-other-aspects
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.3-trial-stopping-rules
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.3.1-temporary-trial-halt
text		1..1	Narrative	Text summary of the section, for human interpretation
section:startEnd	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.4-start-and-end
text		1..1	Narrative	Text summary of the section, for human interpretation
section:access	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section4.5-access-after-trial
text		1..1	Narrative	Text summary of the section, for human interpretation
section:population	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5-trial-population
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.1-population-description
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.2-inclusion-criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.3-exclusion-criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:lifestyle	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4-lifestyle-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.1-dietary-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:substances	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.2-substances-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:activity	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.3-activity-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:other	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.4.4-other-restrictions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:screenFailures	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
code
text		1..1	string	Plain text representation of the concept Required Pattern: section5.5-screen-failure
text		1..1	Narrative	Text summary of the section, for human interpretation
section:intervention	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6-trial-intervention
Slices for section		8..*		Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.1-description-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.2-rationale-for-trial-intervention-regimen
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.3-dosing-and-administration
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition)	A reference to data that supports this section
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.3.1-dose-modification
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition)	A reference to data that supports this section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.4-management-of-overdose
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
section:preparation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5-preparation-storage-handling
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.1-preparation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:storageHandling	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.2-storage-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:accountability	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.5.3-accountability
text		1..1	Narrative	Text summary of the section, for human interpretation
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6-assignment-randomisation-blinding
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.1-assignment
text		1..1	Narrative	Text summary of the section, for human interpretation
section:randomisation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.2-randomisation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:blinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.3-blinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:unblinding	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.6.4-unblinding
text		1..1	Narrative	Text summary of the section, for human interpretation
section:compliance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.7-intervention-compliance
text		1..1	Narrative	Text summary of the section, for human interpretation
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8-noninvestigational-interventions
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.1-background-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rescue	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.2-rescue-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:other	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.8.3-other-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9.1-prohibited-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:permitted	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
code
text		1..1	string	Plain text representation of the concept Required Pattern: section6.9.2-permitted-concomitant-therapy
text		1..1	Narrative	Text summary of the section, for human interpretation
section:dropout	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7-participant-discontinuation
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1-discontinuation-of-trial-intervention
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:temporary	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rechallenge	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.1.3-rechallenge
text		1..1	Narrative	Text summary of the section, for human interpretation
section:withdrawal	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.2-participant-withdrawal
text		1..1	Narrative	Text summary of the section, for human interpretation
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.3-lost-to-follow-up
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
code
text		1..1	string	Plain text representation of the concept Required Pattern: section7.4-participant-stopping-rules
text		1..1	Narrative	Text summary of the section, for human interpretation
section:assessments	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		8..*		Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.1-screening-baseline-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:efficacy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.2-efficacy-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safety	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3-safety-assessments
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.1-physical-examination
text		1..1	Narrative	Text summary of the section, for human interpretation
section:vitals	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.2-vital-signs
text		1..1	Narrative	Text summary of the section, for human interpretation
section:ecg	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.3-electrocardiograms
text		1..1	Narrative	Text summary of the section, for human interpretation
section:laboratory	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.4-clinical-laboratory-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnancy	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.5-pregnancy-testing
text		1..1	Narrative	Text summary of the section, for human interpretation
section:suicidal	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3.6-suicidal-ideation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4-pharmacokinetics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:genetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.5-genetic-testing
text		1..1	Narrative	Text summary of the section, for human interpretation
section:biomarkers	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6-biomarkers
text		1..1	Narrative	Text summary of the section, for human interpretation
section:immunogenicity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.7-immunogenicity-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:economics	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
code
text		1..1	string	Plain text representation of the concept Required Pattern: section8.8-economics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:adverseEvents	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9-adverse-events
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1-definitions
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.1-definitions-adverse-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.2-definitions-serious-adverse-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.1.3-definitions-product-complaints
text		1..1	Narrative	Text summary of the section, for human interpretation
section:collectionMethods	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.2-collection-methods
text		1..1	Narrative	Text summary of the section, for human interpretation
section:recording	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3-recording-and-follow-up
Slices for section		5..*		Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.1-identifying-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:intensity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.2-intensity
text		1..1	Narrative	Text summary of the section, for human interpretation
section:causality	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.3-causality
text		1..1	Narrative	Text summary of the section, for human interpretation
section:recordingEvents	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.4-recording-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:followup	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.3.5-followup
text		1..1	Narrative	Text summary of the section, for human interpretation
section:reporting	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4-reporting-events
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.1-reporting-serious-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.2-regulatory-requirements
text		1..1	Narrative	Text summary of the section, for human interpretation
section:specialInterest	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.3-special-interest
text		1..1	Narrative	Text summary of the section, for human interpretation
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.4.4-disease-related-events
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnancy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5-collection-methods
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5.1-pregnant
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
code
text		1..1	string	Plain text representation of the concept Required Pattern: section9.5.2-pregnant-partner
text		1..1	Narrative	Text summary of the section, for human interpretation
section:statistics	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.1-analysis-sets
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-primary-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3-analysis-secondary-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-exploratory-objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-statistical-model
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.2-intercurrent-events-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5-safety-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.6-other-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.7-interim-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sampleSize	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.8-sample-size-determination
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section10.9-protocol-deviations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:oversight	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11-oversight
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.1-regulatory-considerations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:trialOversight	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2-trial-oversight
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2.1-investigator-responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.2.2-sponsor-responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:committees	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.3-committees
text		1..1	Narrative	Text summary of the section, for human interpretation
section:informedConsent	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4-informed-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-assent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:emergency	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-emergency-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:rescreening	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.1-rescreening-consent-process
text		1..1	Narrative	Text summary of the section, for human interpretation
section:remainingSamples	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.4.2-remaining-samples
text		1..1	Narrative	Text summary of the section, for human interpretation
section:insurance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.5-insurance-and-indemnity
text		1..1	Narrative	Text summary of the section, for human interpretation
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#decisionRights
text		1..1	Narrative	Text summary of the section, for human interpretation
section:criteria	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#criteria
text		1..1	Narrative	Text summary of the section, for human interpretation
section:responsibilities	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
code
text		1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#responsibilities
text		1..1	Narrative	Text summary of the section, for human interpretation
section:riskManagementAndData	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12-risk-management-and-data-governance
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.1-risk-management
text		1..1	Narrative	Text summary of the section, for human interpretation
section:dataGovernance	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.2-data-governance
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sourceData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
code
text		1..1	string	Plain text representation of the concept Required Pattern: section12.3-source-data
text		1..1	Narrative	Text summary of the section, for human interpretation
section:definitions	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13-definitions
Slices for section		4..*		Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1-contraception
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1.1-contraception-definitions
text		1..1	Narrative	Text summary of the section, for human interpretation
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.1.2-contraception-details
text		1..1	Narrative	Text summary of the section, for human interpretation
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.2-clinical-laboratory-tests
text		1..1	Narrative	Text summary of the section, for human interpretation
section:regional	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.3-country-specific-differences
text		1..1	Narrative	Text summary of the section, for human interpretation
section:priorAmendments	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
code
text		1..1	string	Plain text representation of the concept Required Pattern: section13.4-prior-protocol-amendments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:glossary	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
code
text		1..1	string	Plain text representation of the concept Required Pattern: section14-glossary
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
section:references	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
code
text		1..1	string	Plain text representation of the concept Required Pattern: section15-references
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(Citation)	A reference to data that supports this section
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
versionAlgorithm		0..1	string	How to compare versions URL: http://hl7.org/fhir/StructureDefinition/artifact-version profiled by http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
experimental		0..1	boolean	For testing purposes, not real usage URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
description		0..1	markdown	Natural language description of the {{title}} URL: http://hl7.org/fhir/StructureDefinition/artifact-description
purpose		0..1	markdown	Why this {{title}} is defined URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
copyright		0..1	markdown	Use and/or publishing restrictions URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
copyrightLabel		0..1	string	Copyright holder and year(s) URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
approvalDate		0..1	date	When the resource was approved by publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-approvalDate
lastReviewDate		0..1	date	When the resource was last reviewed by the publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-lastReviewDate
effectivePeriod		0..1	Period	When the resource is expected to be used URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-effectivePeriod
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://fevir.net/resources/CodeSystem/179423
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EvidenceReport
display		1..1	string	Representation defined by the system Fixed Value: EvidenceReport
Slices for category	Σ	1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
category:m11report	SΣ	1..1	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
subject	Σ	0..1	Reference(Citation | Classification | EvidenceReportSubject | ResearchStudy)	Who and/or what the composition is about
date	Σ	1..1	dateTime	Composition editing time
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	Σ	1..1	string	Human Readable name/title
Slices for section	C	15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:summary	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Composition)	A reference to data that supports this section
section:overallDesign		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
section:numberOfArms		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:blinding		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:numberOfParticipants		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:duration		0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:committees		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialSchema	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
section:introduction	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:riskSummary		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialProcedures		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherRisk		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoints	SC	1..*	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:objective	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoint	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:estimand	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:design	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:duration	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:endpoints	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interim	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:comparator	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:adaptive	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAspects	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:startEnd	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:access	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:population	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
section:lifestyle	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:substances	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:activity	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:other	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:screenFailures	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:intervention	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:rationale	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
section:preparation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:storageHandling	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:accountability	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:randomisation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:blinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:unblinding	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:compliance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rescue	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:other	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:permitted	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:dropout	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:temporary	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rechallenge	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:withdrawal	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:assessments	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
text	C	0..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:efficacy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safety	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:vitals	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:ecg	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:laboratory	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnancy	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:suicidal	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:genetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:biomarkers	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:immunogenicity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:economics	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:adverseEvents	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:collectionMethods	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:recording	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:intensity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:causality	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:recordingEvents	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:followup	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:reporting	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:specialInterest	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnancy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statistics	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sampleSize	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:oversight	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:trialOversight	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
text	C	0..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:committees	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:informedConsent	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:emergency	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:rescreening	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:remainingSamples	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:insurance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:criteria	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:responsibilities	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:riskManagementAndData	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:dataGovernance	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sourceData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:definitions	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:regional	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:priorAmendments	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:glossary	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
section:references	SC	1..1	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
text	C	1..1	Narrative	Text summary of the section, for human interpretation
entry	C	0..*	Reference(Citation)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.category:m11report	example	ReferencedItemCategoryValueSet

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
versionAlgorithm		0..1	string	How to compare versions URL: http://hl7.org/fhir/StructureDefinition/artifact-version profiled by http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
experimental		0..1	boolean	For testing purposes, not real usage URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
description		0..1	markdown	Natural language description of the {{title}} URL: http://hl7.org/fhir/StructureDefinition/artifact-description
purpose		0..1	markdown	Why this {{title}} is defined URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
copyright		0..1	markdown	Use and/or publishing restrictions URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
copyrightLabel		0..1	string	Copyright holder and year(s) URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
approvalDate		0..1	date	When the resource was approved by publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-approvalDate
lastReviewDate		0..1	date	When the resource was last reviewed by the publisher URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-lastReviewDate
effectivePeriod		0..1	Period	When the resource is expected to be used URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-effectivePeriod
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://fevir.net/resources/CodeSystem/179423
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EvidenceReport
display		1..1	string	Representation defined by the system Fixed Value: EvidenceReport
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for category	Σ	1..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
category:m11report	SΣ	1..1	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
subject	Σ	0..1	Reference(Citation | Classification | EvidenceReportSubject | ResearchStudy)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	Σ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
mode		1..1	CodeableConcept	reviewer | editor | endorser | informant Binding: ContributorRole (preferred)
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	C	15..*	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:summary	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Summary
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1-protocol-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:protocolSynopsis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Synopsis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1-protocol-synopsis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectivesEndpoints	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary and Secondary Objectives and Endpoints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1.1-objectives-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Composition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:overallDesign		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.1.2-overall-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Composition | ResearchStudy)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:numberOfArms		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Number of Arms
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:blinding		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:numberOfParticipants		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Number of Participants
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:duration		0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Arms and Duration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:committees		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Committees
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialSchema	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Schema
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.2-trial-schema
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:scheduleOfActivities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Schedule of Activities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section1.3-schedule-of-activities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(SoaPlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:introduction	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Introduction
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2-introduction
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:purposeOfTrial	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Purpose of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.1-trial-purpose
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:benefitsAndRisks	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Summary of Benefits and Risks
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2-benefits-risks
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:benefitSummary	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Benefit Summary
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.1-benefit-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:riskSummary		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Summary and Mitigation Strategy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:trialIntervention	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Intervention Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.1-trial-intervention-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialProcedures		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Procedure Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.2-trial-procedures-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherRisk		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial-specific Other Risks and Mitigations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.2.3-trial-other-risk-summary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:overallBenefitRisk		1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Overall Benefit:Risk Conclusion
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section2.2.3-overall-benefit-risk-conclusion
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoints	SC	1..*	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Objectives, Endpoints and Estimands
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section3-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:objectiveEndpoint	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective + Associated Endpoint (and Estimand)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section3.1-objective-endpoint-estimand
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		1..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:primarySecondaryExploratory	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Primary/Secondary/Exploratory Classification
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Primary/Secondary/Exploratory
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:objective	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoint	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Endpoint
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Endpoint
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:estimand	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: Estimand
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:design	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.1-description-of-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:stakeholderInput	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Stakeholder Input into Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.1.1-stakeholder-input-into-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rationale	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2-rationale-for-trial-design
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:model	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Intervention Model
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.1-rationale-intervention-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:duration	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Duration
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.2-rationale-duration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:endpoints	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Endpoints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.3-rationale-endpoints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interim	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Interim Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.4-rationale-interim-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:comparator	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Comparator
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.5-rationale-comparator
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:adaptive	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Adaptive or Novel Trial Design
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.6-rationale-adaptive
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAspects	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Other Trial Design Aspects
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.2.7-rationale-other-aspects
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Stopping Rules
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.3-trial-stopping-rules
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:temporaryHalt	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Trial Halt
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.3.1-temporary-trial-halt
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:startEnd	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Start of Trial and End of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.4-start-and-end
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:access	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Access to Trial Intervention After End of Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section4.5-access-after-trial
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:population	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Population
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5-trial-population
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Trial Population and Rationale
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.1-population-description
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:inclusionCriteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Inclusion Criteria
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.2-inclusion-criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exclusionCriteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Exclusion Criteria
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.3-exclusion-criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(CohortDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:lifestyle	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lifestyle Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4-lifestyle-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:dietary	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Meals and Dietary Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.1-dietary-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:substances	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.2-substances-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:activity	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Activity Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.3-activity-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:other	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Activity Restrictions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.4.4-other-restrictions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:screenFailures	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screen Failure and Rescreening
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section5.5-screen-failure
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intervention	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:description	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Description of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.1-description-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rationale	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.2-rationale-for-trial-intervention-regimen
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ExposureDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dosingAdministration	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Administration
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.3-dosing-and-administration
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:doseModification	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Dose Modification
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.3.1-dose-modification
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:treatmentOfOverdose	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Management of Investigational Trial Intervention Overdose
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.4-management-of-overdose
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ActivityDefinition | PlanDefinition)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:preparation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5-preparation-storage-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:preparationIntervention	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Preparation of Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.1-preparation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:storageHandling	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Storage and Handling of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.2-storage-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:accountability	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Accountability of Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.5.3-accountability
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:assignmentAndBlinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6-assignment-randomisation-blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assignment	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Assignment to Investigational Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.1-assignment
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:randomisation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Randomisation
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.2-randomisation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:blinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Blinding
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.3-blinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:unblinding	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Unblinding at the Site
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.6.4-unblinding
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:compliance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigational Trial Intervention Compliance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.7-intervention-compliance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:noninvestigationalTherapy	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Non-Investigational Trial Intervention(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8-noninvestigational-interventions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:background	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Background Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.1-background-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rescue	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rescue Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.2-rescue-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:other	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.8.3-other-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:concomitantTherapy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:prohibited	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prohibited Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9.1-prohibited-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:permitted	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permitted Concomitant Therapy
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section6.9.2-permitted-concomitant-therapy
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dropout	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Discontinuation of Trial Intervention and Withdrawal from Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7-participant-discontinuation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:discontinuation	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Discontinuation of Trial Intervention for Individual Participants
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:permanent	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Permanent Discontinuation of Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:temporary	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Temporary Discontinuation of Trial Intervention
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rechallenge	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Rechallenge
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.1.3-rechallenge
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:withdrawal	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Withdrawal from the Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.2-participant-withdrawal
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:lostToFollowUp	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Lost to Follow-Up
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.3-lost-to-follow-up
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialStoppingRules	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participant Stopping Rules
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section7.4-participant-stopping-rules
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:assessments	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Screening/Baseline Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.1-screening-baseline-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:efficacy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Efficacy Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.2-efficacy-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safety	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Assessments and Procedures
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3-safety-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:physical	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Physical Examination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.1-physical-examination
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:vitals	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Vital Signs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.2-vital-signs
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:ecg	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Electrocardiograms
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.3-electrocardiograms
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:laboratory	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Assessments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.4-clinical-laboratory-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnancy	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pregnancy Testing
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.5-pregnancy-testing
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:suicidal	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.3.6-suicidal-ideation
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Pharmacokinetics
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.4-pharmacokinetics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:genetics	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Genetic Testing
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.5-genetic-testing
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:biomarkers	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Biomarkers
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.6-biomarkers
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:immunogenicity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Immunogenicity Assessments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.7-immunogenicity-assessments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:economics	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Medical Resource Utilisation and Health Economics
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8.8-economics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:adverseEvents	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events, Serious Adverse Events, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:definitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:adverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Adverse Events
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.1-definitions-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:seriousAdverseEventsDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Serious Adverse Events
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.2-definitions-serious-adverse-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:productComplaintsDefinitions	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions of Medical Device Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.1.3-definitions-product-complaints
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:collectionMethods	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.2-collection-methods
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:recording	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3-recording-and-follow-up
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		5..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:identifying	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Identifying AEs, SAEs and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.1-identifying-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intensity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Intensity
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.2-intensity
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:causality	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Causality
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.3-causality
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:recordingEvents	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Recording of AEs, SAEs, Pregnancy and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.4-recording-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:followup	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Follow-up
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.3.5-followup
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:reporting	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4-reporting-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:reportingSAEs	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Reporting of SAEs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.1-reporting-serious-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:regulatoryRequirements	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory Reporting Requirements for SAEs and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.2-regulatory-requirements
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:specialInterest	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Adverse Events of Special Interest
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.3-special-interest
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:diseaseRelatedEvents	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.4.4-disease-related-events
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnancy	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5-collection-methods
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:pregnant	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Who Become Pregnant During the Trial
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5.1-pregnant
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:pregnantPartner	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Participants Whose Partners Become Pregnant
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section9.5.2-pregnant-partner
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statistics	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:analysisSets	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.1-analysis-sets
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Primary Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-primary-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Primary Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.2.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Supporting Secondary Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3-analysis-secondary-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Secondary Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.3.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exploratoryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis of Exploratory Objective
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-exploratory-objective
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Model, Hypothesis, and Method of Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-statistical-model
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Intercurrent Events of Exploratory Estimand
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.2-intercurrent-events-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.4.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.5-safety-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.6-other-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.7-interim-analyses
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sampleSize	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.8-sample-size-determination
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:protocolDeviations	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Protocol Deviations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section10.9-protocol-deviations
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:oversight	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Regulatory, Ethical, and Trial Oversight
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11-oversight
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:regulatory	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Regulatory and Ethical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.1-regulatory-considerations
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:trialOversight	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Trial Oversight
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2-trial-oversight
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:investigatorResponsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Investigator Responsibilities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2.1-investigator-responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sponsorResponsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sponsor Responsibilities
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.2.2-sponsor-responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:committees	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Committees
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.3-committees
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:informedConsent	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4-informed-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:assentProcess	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Assent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-assent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:emergency	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Emergency Consent Process
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.0-emergency-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:rescreening	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Rescreening
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.1-rescreening-consent-process
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:remainingSamples	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.4.2-remaining-samples
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:insurance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Insurance and Indemnity
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.5-insurance-and-indemnity
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:earlySiteClosure	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Early Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:decisionRights	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Decision Rights for Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#decisionRights
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:criteria	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Crteria for Early Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#criteria
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:responsibilities	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Responsibilities Following Early Site Closure
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section11.6-early-site-closure#responsibilities
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:riskManagementAndData	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations: Risk Management and Data Governance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12-risk-management-and-data-governance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:riskManagement	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Risk Management
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.1-risk-management
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:dataGovernance	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Data Governance
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.2-data-governance
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sourceData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Source Data
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section12.3-source-data
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:definitions	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Definitions and Supporting Operational Details
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraception	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1-contraception
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:contraceptionDefinitions	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Definitions Related to Childbearing Potential
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1.1-contraception-definitions
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:contraceptionDetails	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Contraception
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.1.2-contraception-details
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:clinicalLaboratoryTests	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Clinical Laboratory Tests
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.2-clinical-laboratory-tests
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:regional	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Country/Region-Specific Differences
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.3-country-specific-differences
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:priorAmendments	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Prior Protocol Amendment(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section13.4-prior-protocol-amendments
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:glossary	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: Glossary of Terms and Abbreviations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section14-glossary
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(ValueSet | CodeSystem)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:references	SC	1..1	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Appendix: References
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section15-references
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Citation)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.language	required	AllLanguages
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.category:m11report	example	ReferencedItemCategoryValueSet
Composition.attester.mode	preferred	ContributorRole
Composition.event.detail	example	ActCode
Composition.section.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section.orderedBy	preferred	ListOrderCodes
Composition.section.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:summary.orderedBy	preferred	ListOrderCodes
Composition.section:summary.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:overallDesign.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:overallDesign.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:overallDesign.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:blinding.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:blinding.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:blinding.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:duration.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:duration.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:duration.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:protocolSynopsis.section:committees.code	example	DocumentSectionCodes
Composition.section:summary.section:protocolSynopsis.section:committees.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:protocolSynopsis.section:committees.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:trialSchema.code	example	DocumentSectionCodes
Composition.section:summary.section:trialSchema.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:trialSchema.emptyReason	preferred	ListEmptyReasons
Composition.section:summary.section:scheduleOfActivities.code	example	DocumentSectionCodes
Composition.section:summary.section:scheduleOfActivities.orderedBy	preferred	ListOrderCodes
Composition.section:summary.section:scheduleOfActivities.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:introduction.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:purposeOfTrial.code	example	DocumentSectionCodes
Composition.section:introduction.section:purposeOfTrial.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:purposeOfTrial.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.emptyReason	preferred	ListEmptyReasons
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code	example	DocumentSectionCodes
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.orderedBy	preferred	ListOrderCodes
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:endpoints.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:objective.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:objective.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:objective.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.emptyReason	preferred	ListEmptyReasons
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code	example	DocumentSectionCodes
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.orderedBy	preferred	ListOrderCodes
Composition.section:endpoints.section:objectiveEndpoint.section:estimand.emptyReason	preferred	ListEmptyReasons
Composition.section:design.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:design.orderedBy	preferred	ListOrderCodes
Composition.section:design.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:description.code	example	DocumentSectionCodes
Composition.section:design.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:description.section:stakeholderInput.code	example	DocumentSectionCodes
Composition.section:design.section:description.section:stakeholderInput.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:description.section:stakeholderInput.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:model.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:model.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:model.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:duration.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:duration.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:duration.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:endpoints.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:endpoints.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:endpoints.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:interim.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:interim.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:interim.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:comparator.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:comparator.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:comparator.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:adaptive.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:adaptive.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:adaptive.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:rationale.section:otherAspects.code	example	DocumentSectionCodes
Composition.section:design.section:rationale.section:otherAspects.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:rationale.section:otherAspects.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:trialStoppingRules.code	example	DocumentSectionCodes
Composition.section:design.section:trialStoppingRules.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:trialStoppingRules.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code	example	DocumentSectionCodes
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:trialStoppingRules.section:temporaryHalt.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:startEnd.code	example	DocumentSectionCodes
Composition.section:design.section:startEnd.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:startEnd.emptyReason	preferred	ListEmptyReasons
Composition.section:design.section:access.code	example	DocumentSectionCodes
Composition.section:design.section:access.orderedBy	preferred	ListOrderCodes
Composition.section:design.section:access.emptyReason	preferred	ListEmptyReasons
Composition.section:population.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:population.orderedBy	preferred	ListOrderCodes
Composition.section:population.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:description.code	example	DocumentSectionCodes
Composition.section:population.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:inclusionCriteria.code	example	DocumentSectionCodes
Composition.section:population.section:inclusionCriteria.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:inclusionCriteria.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:exclusionCriteria.code	example	DocumentSectionCodes
Composition.section:population.section:exclusionCriteria.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:exclusionCriteria.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:dietary.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:dietary.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:dietary.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:substances.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:substances.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:substances.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:activity.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:activity.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:activity.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:lifestyle.section:other.code	example	DocumentSectionCodes
Composition.section:population.section:lifestyle.section:other.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:lifestyle.section:other.emptyReason	preferred	ListEmptyReasons
Composition.section:population.section:screenFailures.code	example	DocumentSectionCodes
Composition.section:population.section:screenFailures.orderedBy	preferred	ListOrderCodes
Composition.section:population.section:screenFailures.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:intervention.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:description.code	example	DocumentSectionCodes
Composition.section:intervention.section:description.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:description.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:rationale.code	example	DocumentSectionCodes
Composition.section:intervention.section:rationale.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:rationale.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:dosingAdministration.code	example	DocumentSectionCodes
Composition.section:intervention.section:dosingAdministration.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:dosingAdministration.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:dosingAdministration.section:doseModification.code	example	DocumentSectionCodes
Composition.section:intervention.section:dosingAdministration.section:doseModification.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:dosingAdministration.section:doseModification.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:treatmentOfOverdose.code	example	DocumentSectionCodes
Composition.section:intervention.section:treatmentOfOverdose.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:treatmentOfOverdose.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:preparationIntervention.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:preparationIntervention.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:preparationIntervention.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:storageHandling.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:storageHandling.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:storageHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:preparation.section:accountability.code	example	DocumentSectionCodes
Composition.section:intervention.section:preparation.section:accountability.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:preparation.section:accountability.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code	example	DocumentSectionCodes
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:compliance.code	example	DocumentSectionCodes
Composition.section:intervention.section:compliance.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:compliance.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:background.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:background.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:background.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:noninvestigationalTherapy.section:other.code	example	DocumentSectionCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:other.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:noninvestigationalTherapy.section:other.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.section:prohibited.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.section:prohibited.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.section:prohibited.emptyReason	preferred	ListEmptyReasons
Composition.section:intervention.section:concomitantTherapy.section:permitted.code	example	DocumentSectionCodes
Composition.section:intervention.section:concomitantTherapy.section:permitted.orderedBy	preferred	ListOrderCodes
Composition.section:intervention.section:concomitantTherapy.section:permitted.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:dropout.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:permanent.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:permanent.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:permanent.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:temporary.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:temporary.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:temporary.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:discontinuation.section:rechallenge.code	example	DocumentSectionCodes
Composition.section:dropout.section:discontinuation.section:rechallenge.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:discontinuation.section:rechallenge.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:withdrawal.code	example	DocumentSectionCodes
Composition.section:dropout.section:withdrawal.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:withdrawal.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:lostToFollowUp.code	example	DocumentSectionCodes
Composition.section:dropout.section:lostToFollowUp.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:lostToFollowUp.emptyReason	preferred	ListEmptyReasons
Composition.section:dropout.section:trialStoppingRules.code	example	DocumentSectionCodes
Composition.section:dropout.section:trialStoppingRules.orderedBy	preferred	ListOrderCodes
Composition.section:dropout.section:trialStoppingRules.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:assessments.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:screeningBaseline.code	example	DocumentSectionCodes
Composition.section:assessments.section:screeningBaseline.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:screeningBaseline.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:efficacy.code	example	DocumentSectionCodes
Composition.section:assessments.section:efficacy.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:efficacy.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:physical.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:physical.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:physical.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:vitals.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:vitals.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:vitals.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:ecg.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:ecg.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:ecg.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:laboratory.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:laboratory.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:laboratory.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:pregnancy.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:pregnancy.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:pregnancy.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:safety.section:suicidal.code	example	DocumentSectionCodes
Composition.section:assessments.section:safety.section:suicidal.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:safety.section:suicidal.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:pharmacokinetics.code	example	DocumentSectionCodes
Composition.section:assessments.section:pharmacokinetics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:pharmacokinetics.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:genetics.code	example	DocumentSectionCodes
Composition.section:assessments.section:genetics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:genetics.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:biomarkers.code	example	DocumentSectionCodes
Composition.section:assessments.section:biomarkers.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:biomarkers.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:immunogenicity.code	example	DocumentSectionCodes
Composition.section:assessments.section:immunogenicity.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:immunogenicity.emptyReason	preferred	ListEmptyReasons
Composition.section:assessments.section:economics.code	example	DocumentSectionCodes
Composition.section:assessments.section:economics.orderedBy	preferred	ListOrderCodes
Composition.section:assessments.section:economics.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:adverseEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:collectionMethods.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:collectionMethods.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:collectionMethods.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:identifying.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:identifying.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:identifying.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:intensity.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:intensity.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:intensity.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:causality.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:causality.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:causality.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:recordingEvents.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:recordingEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:recordingEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:recording.section:followup.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:recording.section:followup.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:recording.section:followup.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:reportingSAEs.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:specialInterest.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:specialInterest.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:specialInterest.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.section:pregnant.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnant.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnant.emptyReason	preferred	ListEmptyReasons
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code	example	DocumentSectionCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.orderedBy	preferred	ListOrderCodes
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:statistics.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisSets.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisSets.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisSets.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:missingData.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code	example	DocumentSectionCodes
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:safetyAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:safetyAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:safetyAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:otherAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:otherAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:otherAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:interimAnalyses.code	example	DocumentSectionCodes
Composition.section:statistics.section:interimAnalyses.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:interimAnalyses.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:sampleSize.code	example	DocumentSectionCodes
Composition.section:statistics.section:sampleSize.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:sampleSize.emptyReason	preferred	ListEmptyReasons
Composition.section:statistics.section:protocolDeviations.code	example	DocumentSectionCodes
Composition.section:statistics.section:protocolDeviations.orderedBy	preferred	ListOrderCodes
Composition.section:statistics.section:protocolDeviations.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:oversight.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:regulatory.code	example	DocumentSectionCodes
Composition.section:oversight.section:regulatory.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:regulatory.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:committees.code	example	DocumentSectionCodes
Composition.section:oversight.section:committees.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:committees.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:assentProcess.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:assentProcess.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:assentProcess.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:emergency.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:emergency.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:emergency.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:rescreening.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:rescreening.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:rescreening.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:informedConsent.section:remainingSamples.code	example	DocumentSectionCodes
Composition.section:oversight.section:informedConsent.section:remainingSamples.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:informedConsent.section:remainingSamples.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:insurance.code	example	DocumentSectionCodes
Composition.section:oversight.section:insurance.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:insurance.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:criteria.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:criteria.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:criteria.emptyReason	preferred	ListEmptyReasons
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code	example	DocumentSectionCodes
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.orderedBy	preferred	ListOrderCodes
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:riskManagementAndData.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:riskManagement.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:riskManagement.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:riskManagement.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:dataGovernance.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:dataGovernance.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:dataGovernance.emptyReason	preferred	ListEmptyReasons
Composition.section:riskManagementAndData.section:sourceData.code	example	DocumentSectionCodes
Composition.section:riskManagementAndData.section:sourceData.orderedBy	preferred	ListOrderCodes
Composition.section:riskManagementAndData.section:sourceData.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:definitions.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.section:contraceptionDefinitions.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:contraception.section:contraceptionDetails.code	example	DocumentSectionCodes
Composition.section:definitions.section:contraception.section:contraceptionDetails.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:contraception.section:contraceptionDetails.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:clinicalLaboratoryTests.code	example	DocumentSectionCodes
Composition.section:definitions.section:clinicalLaboratoryTests.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:clinicalLaboratoryTests.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:regional.code	example	DocumentSectionCodes
Composition.section:definitions.section:regional.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:regional.emptyReason	preferred	ListEmptyReasons
Composition.section:definitions.section:priorAmendments.code	example	DocumentSectionCodes
Composition.section:definitions.section:priorAmendments.orderedBy	preferred	ListOrderCodes
Composition.section:definitions.section:priorAmendments.emptyReason	preferred	ListEmptyReasons
Composition.section:glossary.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:glossary.orderedBy	preferred	ListOrderCodes
Composition.section:glossary.emptyReason	preferred	ListEmptyReasons
Composition.section:references.code	extensible	EvidenceReportSectionCode_Value_Set
Composition.section:references.orderedBy	preferred	ListOrderCodes
Composition.section:references.emptyReason	preferred	ListEmptyReasons

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section, Composition.section:summary, Composition.section:introduction, Composition.section:endpoints, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:riskManagementAndData, Composition.section:definitions, Composition.section:glossary, Composition.section:references	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from EvidenceReport

Summary

Mandatory: 209 elements (225 nested mandatory elements)
Must-Support: 162 elements

Structures

This structure refers to these other structures:

• SoaPlanDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition)
• VariableDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition)
• CohortDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition)
• ExposureDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition)
• EndpointAnalysisPlan (http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan)

Slices

This structure defines the following Slices:

• The element Composition.category is sliced based on the value of value:text
• The element Composition.section is sliced based on the value of value:code.text
• The element Composition.section.section is sliced based on the value of value:code.text
• The element Composition.section.section.section is sliced based on the value of value:code.text
• The element Composition.section.section.section.section is sliced based on the value of value:code.text

Maturity: 1