Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Resource Profile: M11 Research Study Profile

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 2 | Computable Name: M11_ResearchStudyProfile
Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: licenses.html

Constraint of ResearchStudy to M11 Guidance An instance of this profile represents a single version of the protocol definition. Previous amendments are represented by further instances of ResearchStudy linked through the relatesTo attribute.

### Must Support Elements

identifier - there SHALL be a value assigned by the Sponsor value §3

identifier - there SHOULD be a value assigned by the Regulator §4

identifier.type - SHALL be populated so that the different identifiers required by M11 can be recognised§5

title - M11 requirement, SHALL be present§6

m11-research-study - M11 requirement, extension SHALL be populated§7

m11-protocol-amendment - M11 requirement, extension SHALL be populated§8

phase - M11 requirement, SHALL be present§9

associatedParty.party.reference - M11 requirement, SHALL have a Sponsor name and address§10

m11-approval - M11 requirement, SHALL have either a date or location for approval of protocol§11

Usages:

- Examples for this Profile: ResearchStudy/Exemplar-ResearchStudy-001, ResearchStudy/Exemplar-ResearchStudy-Current-Amendment, ResearchStudy/JPMA0001-eng, ResearchStudy/JPMA0001-jpn... Show 4 more, ResearchStudy/ResearchStudy-Composition-Section-Per-Section-001, ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001, ResearchStudy/ResearchStudy-Narrative-Complex-001 and ResearchStudy/ResearchStudy-Single-Composition-001

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S C | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | Business Identifier for study
use | ?! | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible)
title | S Σ | 0..1 | string | Human readable name of the study
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
phase | S Σ | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
associatedParty |  | 0..* | BackboneElement | Sponsors, collaborators, and other parties
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation)
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.identifier.​use | Base | required | IdentifierUse | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
date-required | warning | ResearchStudy.extension:approval | At least one of approvalDate or signatureUrl SHOULD be populated. | `extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | ResearchStudy | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | ResearchStudy | 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()`
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
identifier | S | 1..* | Identifier | Business Identifier for study
type | ?!S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible)
coding |  |  |  |
code |  | 1..1 | code | Symbol in syntax defined by the system
title | S | 0..1 | string | Human readable name of the study
label |  |  |  |
type |  | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: UDP Study Title Type Value Set (extensible)
relatesTo |  |  |  |
type |  | 1..1 | code | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
phase | S | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study
associatedParty |  |  |  |
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party |  |  |  |
reference | S | 0..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.label.​type | Base | extensible | UDP Study Title Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
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
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S C | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
url |  | 0..1 | uri | Canonical identifier for this study resource
identifier | S Σ | 1..* | Identifier | Business Identifier for study
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?! | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type 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 |  | 0..* | Coding | Code defined by a terminology system
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
system |  | 0..1 | uri | Identity of the terminology system
version |  | 0..1 | string | Version of the system - if relevant
code | C | 1..1 | code | Symbol in syntax defined by the system
display | C | 0..1 | string | Representation defined by the system
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
system |  | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | C | 0..1 | string | The value that is unique Example General: 123456
period |  | 0..1 | Period | Time period when id is/was valid for use
assigner |  | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
version |  | 0..1 | string | The business version for the study record
name |  | 0..1 | string | Name for this study (computer friendly)
title | S Σ | 0..1 | string | Human readable name of the study
label |  | 0..* | BackboneElement | Additional names for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: UDP Study Title Type Value Set (extensible)
value |  | 0..1 | string | The name
protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study
citeAs |  | 0..1 | markdown | How to cite this ResearchStudy
relatesTo |  | 0..* | BackboneElement | Relationships to other Resources
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | code | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
target[x] |  | 1..1 |  | The artifact that is related to this ResearchStudy
targetUri |  |  | uri |
targetAttachment |  |  | Attachment |
targetCanonical |  |  | canonical(Resource) |
targetReference |  |  | Reference(Resource) |
targetMarkdown |  |  | markdown |
date |  | 0..1 | dateTime | Date the resource last changed
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
condition | Σ | 0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ResearchStudyFocusType (example): Some example codes.
region | Σ | 0..* | CodeableConcept | Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
descriptionSummary |  | 0..1 | markdown | Brief text explaining the study
description |  | 0..1 | markdown | Detailed narrative of the study
period | Σ | 0..1 | Period | When the study began and ended
site | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted
note |  | 0..* | Annotation | Comments made about the study
classifier |  | 0..* | CodeableConcept | Classification for the study Binding: ResearchStudyClassifiers (example): desc.
associatedParty |  | 0..* | BackboneElement | Sponsors, collaborators, and other parties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Name of associated party
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
period |  | 0..* | Period | When active in the role
classifier |  | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
type |  | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | C | 0..1 | string | Text alternative for the resource
progressStatus |  | 0..* | BackboneElement | Status of study with time for that status
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
state |  | 1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn.
actual |  | 0..1 | boolean | Actual if true else anticipated
period |  | 0..1 | Period | Date range
whyStopped | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
recruitment | Σ | 0..1 | BackboneElement | Target or actual group of participants enrolled in study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
targetNumber |  | 0..1 | unsignedInt | Estimated total number of participants to be enrolled
actualNumber |  | 0..1 | unsignedInt | Actual total number of participants enrolled in study
eligibility |  | 0..1 | Reference(Group) | Inclusion and exclusion criteria
actualGroup | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study
comparisonGroup |  | 0..* | BackboneElement | Defined path through the study for a subject
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
targetNumber |  | 0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group
actualNumber |  | 0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group
eligibility |  | 0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group
observedGroup |  | 0..1 | Reference(Group) | Group of participants who were enrolled in the comparison group
objective |  | 0..* | BackboneElement | A goal for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Label for the objective
type |  | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
description |  | 0..1 | markdown | Description of the objective
outcomeMeasure |  | 0..* | BackboneElement | A variable measured during the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Label for the outcome measure
type |  | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn.
description |  | 0..1 | markdown | Description of the outcome measure
endpoint |  | 1..1 | Reference(EvidenceVariable) | Definition of the outcome measure
population |  | 0..1 | Reference(Group) | Population for this estimand
intervention |  | 0..1 | Reference(Group) | Comparison group of interest
comparator |  | 0..1 | Reference(Group) | Comparison group for comparison
summaryMeasure |  | 0..1 | CodeableConcept | Statistical measure for treatment effect estimate Binding: StatisticType (example): The type of a statistic, e.g. relative risk or mean.
eventHandling |  | 0..* | BackboneElement | Handling of intercurrent event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
event |  | 0..1 | CodeableConcept | The event
group |  | 0..1 | CodeableConcept | The group that is affected by this event handling
handling |  | 0..1 | CodeableConcept | How the data is handled
description |  | 0..1 | markdown | Text summary of event handling
result | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport | Evidence) | Link to results generated during the study
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.language | Base | required | All Languages | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​use | Base | required | IdentifierUse | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.label.​type | Base | extensible | UDP Study Title Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.relatesTo.​type | Base | required | Artifact Relationship Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.primaryPurposeType | Base | preferred | Research Study Primary Purpose Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.studyDesign | Base | preferred | Study Design | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.keyword | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.region | Base | extensible | Jurisdiction ValueSet | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.classifier | Base | example | Research Study Classifiers | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.associatedParty.​classifier | Base | example | Research Study Party Organization Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​party.type | Base | extensible | Resource Types | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.progressStatus.​state | Base | extensible | Research Study Status | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.whyStopped | Base | example | Research Study Reason Stopped | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​type | Base | preferred | Research Study Objective Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​outcomeMeasure.type | Base | preferred | Research Study Objective Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​outcomeMeasure.summaryMeasure | Base | example | Statistic Type | 📍6.0.0-ballot3 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
date-required | warning | ResearchStudy.extension:approval | At least one of approvalDate or signatureUrl SHOULD be populated. | `extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | ResearchStudy | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | ResearchStudy | 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()`
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Summary

Mandatory: 4 elements(1 nested mandatory element)
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S C | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 1..* | Identifier | Business Identifier for study
use | ?! | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible)
title | S Σ | 0..1 | string | Human readable name of the study
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
phase | S Σ | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
associatedParty |  | 0..* | BackboneElement | Sponsors, collaborators, and other parties
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation)
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.identifier.​use | Base | required | IdentifierUse | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
date-required | warning | ResearchStudy.extension:approval | At least one of approvalDate or signatureUrl SHOULD be populated. | `extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | ResearchStudy | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | ResearchStudy | 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()`
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Differential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
identifier | S | 1..* | Identifier | Business Identifier for study
type | ?!S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible)
coding |  |  |  |
code |  | 1..1 | code | Symbol in syntax defined by the system
title | S | 0..1 | string | Human readable name of the study
label |  |  |  |
type |  | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: UDP Study Title Type Value Set (extensible)
relatesTo |  |  |  |
type |  | 1..1 | code | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
phase | S | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study
associatedParty |  |  |  |
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party |  |  |  |
reference | S | 0..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.label.​type | Base | extensible | UDP Study Title Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ResearchStudy | C | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
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
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:narrative | S | 0..* | Reference(Research Study Narratives) | Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment | S | 0..1 | (Complex) | Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement |  | 0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval | S C | 0..1 | (Complex) | Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study | S | 1..1 | (Complex) | Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
url |  | 0..1 | uri | Canonical identifier for this study resource
identifier | S Σ | 1..* | Identifier | Business Identifier for study
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?! | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S | 1..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type 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 |  | 0..* | Coding | Code defined by a terminology system
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
system |  | 0..1 | uri | Identity of the terminology system
version |  | 0..1 | string | Version of the system - if relevant
code | C | 1..1 | code | Symbol in syntax defined by the system
display | C | 0..1 | string | Representation defined by the system
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
system |  | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | C | 0..1 | string | The value that is unique Example General: 123456
period |  | 0..1 | Period | Time period when id is/was valid for use
assigner |  | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
version |  | 0..1 | string | The business version for the study record
name |  | 0..1 | string | Name for this study (computer friendly)
title | S Σ | 0..1 | string | Human readable name of the study
label |  | 0..* | BackboneElement | Additional names for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: UDP Study Title Type Value Set (extensible)
value |  | 0..1 | string | The name
protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study
citeAs |  | 0..1 | markdown | How to cite this ResearchStudy
relatesTo |  | 0..* | BackboneElement | Relationships to other Resources
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | code | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
target[x] |  | 1..1 |  | The artifact that is related to this ResearchStudy
targetUri |  |  | uri |
targetAttachment |  |  | Attachment |
targetCanonical |  |  | canonical(Resource) |
targetReference |  |  | Reference(Resource) |
targetMarkdown |  |  | markdown |
date |  | 0..1 | dateTime | Date the resource last changed
status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
phase | S Σ | 0..1 | CodeableConcept | Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
focus |  | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
condition | Σ | 0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ResearchStudyFocusType (example): Some example codes.
region | Σ | 0..* | CodeableConcept | Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
descriptionSummary |  | 0..1 | markdown | Brief text explaining the study
description |  | 0..1 | markdown | Detailed narrative of the study
period | Σ | 0..1 | Period | When the study began and ended
site | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted
note |  | 0..* | Annotation | Comments made about the study
classifier |  | 0..* | CodeableConcept | Classification for the study Binding: ResearchStudyClassifiers (example): desc.
associatedParty |  | 0..* | BackboneElement | Sponsors, collaborators, and other parties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Name of associated party
role |  | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
period |  | 0..* | Period | When active in the role
classifier |  | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
type |  | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | C | 0..1 | string | Text alternative for the resource
progressStatus |  | 0..* | BackboneElement | Status of study with time for that status
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
state |  | 1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn.
actual |  | 0..1 | boolean | Actual if true else anticipated
period |  | 0..1 | Period | Date range
whyStopped | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
recruitment | Σ | 0..1 | BackboneElement | Target or actual group of participants enrolled in study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
targetNumber |  | 0..1 | unsignedInt | Estimated total number of participants to be enrolled
actualNumber |  | 0..1 | unsignedInt | Actual total number of participants enrolled in study
eligibility |  | 0..1 | Reference(Group) | Inclusion and exclusion criteria
actualGroup | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study
comparisonGroup |  | 0..* | BackboneElement | Defined path through the study for a subject
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
targetNumber |  | 0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group
actualNumber |  | 0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group
eligibility |  | 0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group
observedGroup |  | 0..1 | Reference(Group) | Group of participants who were enrolled in the comparison group
objective |  | 0..* | BackboneElement | A goal for the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Label for the objective
type |  | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
description |  | 0..1 | markdown | Description of the objective
outcomeMeasure |  | 0..* | BackboneElement | A variable measured during the study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 0..1 | string | Label for the outcome measure
type |  | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn.
description |  | 0..1 | markdown | Description of the outcome measure
endpoint |  | 1..1 | Reference(EvidenceVariable) | Definition of the outcome measure
population |  | 0..1 | Reference(Group) | Population for this estimand
intervention |  | 0..1 | Reference(Group) | Comparison group of interest
comparator |  | 0..1 | Reference(Group) | Comparison group for comparison
summaryMeasure |  | 0..1 | CodeableConcept | Statistical measure for treatment effect estimate Binding: StatisticType (example): The type of a statistic, e.g. relative risk or mean.
eventHandling |  | 0..* | BackboneElement | Handling of intercurrent event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
event |  | 0..1 | CodeableConcept | The event
group |  | 0..1 | CodeableConcept | The group that is affected by this event handling
handling |  | 0..1 | CodeableConcept | How the data is handled
description |  | 0..1 | markdown | Text summary of event handling
result | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport | Evidence) | Link to results generated during the study
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
ResearchStudy.language | Base | required | All Languages | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​use | Base | required | IdentifierUse | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.identifier.​type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.label.​type | Base | extensible | UDP Study Title Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.relatesTo.​type | Base | required | Artifact Relationship Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.primaryPurposeType | Base | preferred | Research Study Primary Purpose Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set Terminology | 📦1.0.0-ballot2 | This IG
ResearchStudy.studyDesign | Base | preferred | Study Design | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.keyword | Base | example | Research Study Focus Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.region | Base | extensible | Jurisdiction ValueSet | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.classifier | Base | example | Research Study Classifiers | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot2 | This IG
ResearchStudy.associatedParty.​classifier | Base | example | Research Study Party Organization Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.associatedParty.​party.type | Base | extensible | Resource Types | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.progressStatus.​state | Base | extensible | Research Study Status | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.whyStopped | Base | example | Research Study Reason Stopped | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​type | Base | preferred | Research Study Objective Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​outcomeMeasure.type | Base | preferred | Research Study Objective Type | 📍6.0.0-ballot3 | FHIR Std.
ResearchStudy.objective.​outcomeMeasure.summaryMeasure | Base | example | Statistic Type | 📍6.0.0-ballot3 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
date-required | warning | ResearchStudy.extension:approval | At least one of approvalDate or signatureUrl SHOULD be populated. | `extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | ResearchStudy | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | ResearchStudy | 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()`
identifier-required | error | ResearchStudy | The identifier MUST be populated with at least a Sponsor identifier | `identifier.exists()`

Summary

Mandatory: 4 elements(1 nested mandatory element)
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
- http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study

Maturity: 2

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