Extensions for Using Data Elements from FHIR R5 in FHIR R4B
0.1.0 - STU International flag

Extensions for Using Data Elements from FHIR R5 in FHIR R4B - Downloaded Version null See the Directory of published versions

Resource Profile: Profile_R5_ResearchStudy_R4B

Official URL: http://hl7.org/fhir/5.0/StructureDefinition/profile-ResearchStudy Version: 0.1.0
Standards status: Trial-use Maturity Level: 0 Computable Name: Profile_R5_ResearchStudy_R4B

This cross-version profile allows R5 ResearchStudy content to be represented via FHIR R4B ResearchStudy resources.

Usages:

  • This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
Constraints: ext-1
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
Constraints: ext-1
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
Constraints: ext-1
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
Constraints: ext-1
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
Constraints: ext-1
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
Constraints: ext-1
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
Constraints: ext-1
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
Constraints: ext-1
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
Constraints: ext-1
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
Constraints: ext-1
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
Constraints: ext-1
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
Constraints: ext-1
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
Constraints: ext-1
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
Constraints: ext-1
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
Constraints: ext-1
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Constraints: ext-1
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
Constraints: ext-1

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required ResearchStudyStatus 📍4.3.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(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 ResearchStudy.implicitRules, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
... status
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... focus
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:focus 0..* CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: focus additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus
Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:eligibility 0..1 Reference(Resource) R5: Inclusion and exclusion criteria additional types
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
... site
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:site 0..* Reference(Resource) R5: site
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
... arm
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:linkId 0..1 id R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId
..... extension:intendedExposure 0..* Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: Interventions or exposures in this comparisonGroup or cohort (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure
..... extension:observedGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study comparisonGroup (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup
... objective
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:description 0..1 markdown R5: Description of the objective (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... 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: CommonLanguages (preferred): IETF language tag
Additional BindingsPurpose
AllLanguages Max Binding
... 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
Constraints: dom-r4b
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
Constraints: ext-1
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
Constraints: ext-1
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
Constraints: ext-1
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
Constraints: ext-1
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
Constraints: ext-1
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
Constraints: ext-1
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
Constraints: ext-1
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
Constraints: ext-1
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
Constraints: ext-1
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
Constraints: ext-1
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
Constraints: ext-1
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
Constraints: ext-1
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
Constraints: ext-1
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
Constraints: ext-1
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
Constraints: ext-1
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Constraints: ext-1
... identifier Σ 0..* Identifier Business Identifier for study
... title Σ 0..1 string Name for this study
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 0..* Reference(ResearchStudy) Part of larger study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
Constraints: ext-1
.... value 0..1 code Primitive value for code
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... category Σ 0..* CodeableConcept Classifications for the study
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:focus 0..* CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: focus additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus
Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus
Constraints: ext-1
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(Group) Inclusion & exclusion criteria
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:eligibility 0..1 Reference(Resource) R5: Inclusion and exclusion criteria additional types
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
Constraints: ext-1
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
.... display Σ 0..1 string Text alternative for the resource
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(Practitioner | PractitionerRole) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(Location) Facility where study activities are conducted
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:site 0..1 Reference(Resource) R5: site
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
Constraints: ext-1
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
.... display Σ 0..1 string Text alternative for the resource
... reasonStopped 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.
... note 0..* Annotation Comments made about the study
... arm 0..* BackboneElement Defined path through the study for a subject
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:linkId 0..1 id R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId
Constraints: ext-1
..... extension:intendedExposure 0..* Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: Interventions or exposures in this comparisonGroup or cohort (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure
Constraints: ext-1
..... extension:observedGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study comparisonGroup (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup
Constraints: ext-1
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Constraints: ext-1
.... name 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:description 0..1 markdown R5: Description of the objective (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description
Constraints: ext-1
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Constraints: ext-1
.... 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.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base preferred Common Languages 📍4.3.0 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.3.0 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.3.0 FHIR Std.
ResearchStudy.phase Base example ResearchStudyPhase 📍4.3.0 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.3.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.3.0 FHIR Std.
ResearchStudy.enrollment.​type Base extensible ResourceType 📍4.3.0 FHIR Std.
ResearchStudy.site.type Base extensible ResourceType 📍4.3.0 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.3.0 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.3.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(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()
dom-r4b warning ResearchStudy.contained Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1 error ResearchStudy.meta, ResearchStudy.implicitRules, ResearchStudy.language, ResearchStudy.text, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.identifier, ResearchStudy.title, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.primaryPurposeType, ResearchStudy.phase, ResearchStudy.category, ResearchStudy.focus, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.focus.coding, ResearchStudy.focus.text, ResearchStudy.condition, ResearchStudy.contact, ResearchStudy.relatedArtifact, ResearchStudy.keyword, ResearchStudy.location, ResearchStudy.description, ResearchStudy.enrollment, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.enrollment.reference, ResearchStudy.enrollment.type, ResearchStudy.enrollment.identifier, ResearchStudy.enrollment.display, ResearchStudy.period, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.site.reference, ResearchStudy.site.type, ResearchStudy.site.identifier, ResearchStudy.site.display, ResearchStudy.reasonStopped, ResearchStudy.note, ResearchStudy.arm, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.arm.name, ResearchStudy.arm.type, ResearchStudy.arm.description, ResearchStudy.objective, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension, ResearchStudy.objective.name, ResearchStudy.objective.type All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchStudy

Summary

Extensions

This structure refers to these extensions:

Maturity: 0

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
Constraints: ext-1
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
Constraints: ext-1
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
Constraints: ext-1
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
Constraints: ext-1
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
Constraints: ext-1
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
Constraints: ext-1
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
Constraints: ext-1
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
Constraints: ext-1
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
Constraints: ext-1
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
Constraints: ext-1
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
Constraints: ext-1
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
Constraints: ext-1
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
Constraints: ext-1
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
Constraints: ext-1
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
Constraints: ext-1
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Constraints: ext-1
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
Constraints: ext-1

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required ResearchStudyStatus 📍4.3.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(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 ResearchStudy.implicitRules, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
... status
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... focus
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:focus 0..* CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: focus additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus
Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:eligibility 0..1 Reference(Resource) R5: Inclusion and exclusion criteria additional types
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
... site
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:site 0..* Reference(Resource) R5: site
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
... arm
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:linkId 0..1 id R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId
..... extension:intendedExposure 0..* Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: Interventions or exposures in this comparisonGroup or cohort (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure
..... extension:observedGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study comparisonGroup (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup
... objective
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:description 0..1 markdown R5: Description of the objective (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy(4.3.0) Investigation to increase healthcare-related patient-independent knowledge
... 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: CommonLanguages (preferred): IETF language tag
Additional BindingsPurpose
AllLanguages Max Binding
... 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
Constraints: dom-r4b
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
.... extension:url 0..1 uri R5: Canonical identifier for this study resource (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
Constraints: ext-1
.... extension:version 0..1 string R5: The business version for the study record (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
Constraints: ext-1
.... extension:name 0..1 string R5: Name for this study (computer friendly) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
Constraints: ext-1
.... extension:label 0..* (Complex) R5: Additional names for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
Constraints: ext-1
.... extension:date 0..1 dateTime R5: Date the resource last changed (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
Constraints: ext-1
.... extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics.
Constraints: ext-1
.... extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
Constraints: ext-1
.... extension:classifier 0..* CodeableConcept R5: Classification for the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc.
Constraints: ext-1
.... extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
Constraints: ext-1
.... extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
Constraints: ext-1
.... extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
Constraints: ext-1
.... extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
Constraints: ext-1
.... extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
Constraints: ext-1
.... extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
Constraints: ext-1
.... extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
Constraints: ext-1
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Constraints: ext-1
... identifier Σ 0..* Identifier Business Identifier for study
... title Σ 0..1 string Name for this study
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 0..* Reference(ResearchStudy) Part of larger study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:status 0..1 code R5: draft | active | retired | unknown additional codes
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
Constraints: ext-1
.... value 0..1 code Primitive value for code
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... category Σ 0..* CodeableConcept Classifications for the study
Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
... focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
Binding Description: (example): Codes for medications, devices and other interventions.
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:focus 0..* CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: focus additional types
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus
Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus
Constraints: ext-1
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(Group) Inclusion & exclusion criteria
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:eligibility 0..1 Reference(Resource) R5: Inclusion and exclusion criteria additional types
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
Constraints: ext-1
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
.... display Σ 0..1 string Text alternative for the resource
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(Practitioner | PractitionerRole) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(Location) Facility where study activities are conducted
.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:site 0..1 Reference(Resource) R5: site
URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
Constraints: ext-1
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible)
.... identifier Σ 0..1 Identifier Logical reference, when literal reference is not known
.... display Σ 0..1 string Text alternative for the resource
... reasonStopped 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.
... note 0..* Annotation Comments made about the study
... arm 0..* BackboneElement Defined path through the study for a subject
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:linkId 0..1 id R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId
Constraints: ext-1
..... extension:intendedExposure 0..* Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: Interventions or exposures in this comparisonGroup or cohort (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure
Constraints: ext-1
..... extension:observedGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) R5: Group of participants who were enrolled in study comparisonGroup (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup
Constraints: ext-1
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Constraints: ext-1
.... name 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1
..... extension:description 0..1 markdown R5: Description of the objective (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description
Constraints: ext-1
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
Constraints: ext-1
.... 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.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base preferred Common Languages 📍4.3.0 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.3.0 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.3.0 FHIR Std.
ResearchStudy.phase Base example ResearchStudyPhase 📍4.3.0 FHIR Std.
ResearchStudy.category Base example Not State Unknown
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.3.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.3.0 FHIR Std.
ResearchStudy.enrollment.​type Base extensible ResourceType 📍4.3.0 FHIR Std.
ResearchStudy.site.type Base extensible ResourceType 📍4.3.0 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.3.0 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.3.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(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()
dom-r4b warning ResearchStudy.contained Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1 error ResearchStudy.meta, ResearchStudy.implicitRules, ResearchStudy.language, ResearchStudy.text, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.identifier, ResearchStudy.title, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.primaryPurposeType, ResearchStudy.phase, ResearchStudy.category, ResearchStudy.focus, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.focus.coding, ResearchStudy.focus.text, ResearchStudy.condition, ResearchStudy.contact, ResearchStudy.relatedArtifact, ResearchStudy.keyword, ResearchStudy.location, ResearchStudy.description, ResearchStudy.enrollment, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.enrollment.reference, ResearchStudy.enrollment.type, ResearchStudy.enrollment.identifier, ResearchStudy.enrollment.display, ResearchStudy.period, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.site.reference, ResearchStudy.site.type, ResearchStudy.site.identifier, ResearchStudy.site.display, ResearchStudy.reasonStopped, ResearchStudy.note, ResearchStudy.arm, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.arm.name, ResearchStudy.arm.type, ResearchStudy.arm.description, ResearchStudy.objective, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension, ResearchStudy.objective.name, ResearchStudy.objective.type All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchStudy

Summary

Extensions

This structure refers to these extensions:

Maturity: 0

 

Other representations of profile: CSV, Excel, Schematron