Requirements Federated Learning and mUlti-party computation Techniques for prostatE cancer
0.1.0 - ci-build
Funded by the European Union

Requirements Federated Learning and mUlti-party computation Techniques for prostatE cancer, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/flute-requirements/ and changes regularly. See the Directory of published versions

Resource Profile: PR-ResearchStudy ( Experimental )

Official URL: https://flute.com/StructureDefinition/PR-ResearchStudy Version: 0.1.0
Draft as of 2026-01-30 Computable Name: PR_ResearchStudy

A profile for the use of the ResearchStudy resource for managing research studies.

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 Investigation to increase healthcare-related patient-independent knowledge
... 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:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... 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 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: Research Study Phase Code (required)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG

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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error 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()

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... phase 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: Research Study Phase Code (required)
... recruitment
.... eligibility 0..1 Reference(PR-EvidenceVariable) Inclusion and exclusion criteria

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
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:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
... version 0..1 string The business version for the study record
... name 0..1 string Name for this study (computer friendly)
... title 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: TitleType (extensible): desc.
.... 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
... relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
... 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 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: Research Study Phase Code (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 | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common 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 Description: (example): Words associated with the study that may be useful in discovery.
... 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-director | study-chair
Binding: ResearchStudyPartyRole (extensible): desc.
.... 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)
... 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(PR-EvidenceVariable) 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
.... linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
.... name 1..1 string Label for study comparisonGroup
.... type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
.... description 0..1 markdown Short explanation of study path
.... intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
.... observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
... 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
.... type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
.... description 0..1 markdown Description of the outcome
.... reference 0..1 Reference(EvidenceVariable) Structured outcome definition
... result Σ 0..* Reference(EvidenceReport | Citation | DiagnosticReport) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchStudy.label.​type Base extensible Title Type 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍5.0.0 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍5.0.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 FHIR Std.
ResearchStudy.whyStopped Base example Research Study Reason Stopped 📍5.0.0 FHIR Std.
ResearchStudy.comparisonGroup.​type Base extensible Research Study Arm Type 📍5.0.0 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍5.0.0 FHIR Std.
ResearchStudy.outcomeMeasure.​type Base preferred Research Study Objective Type 📍5.0.0 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error 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()

This structure is derived from ResearchStudy

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... 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:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... 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 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: Research Study Phase Code (required)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG

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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error 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()

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... phase 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: Research Study Phase Code (required)
... recruitment
.... eligibility 0..1 Reference(PR-EvidenceVariable) Inclusion and exclusion criteria

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
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:datamart 1..1 (Complex) EXT-Datamart
URL: https://www.isis.com/StructureDefinition/EXT-Datamart
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
... version 0..1 string The business version for the study record
... name 0..1 string Name for this study (computer friendly)
... title 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: TitleType (extensible): desc.
.... 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
... relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
... 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 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: Research Study Phase Code (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 | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common 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 Description: (example): Words associated with the study that may be useful in discovery.
... 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-director | study-chair
Binding: ResearchStudyPartyRole (extensible): desc.
.... 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)
... 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(PR-EvidenceVariable) 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
.... linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
.... name 1..1 string Label for study comparisonGroup
.... type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
.... description 0..1 markdown Short explanation of study path
.... intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
.... observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
... 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
.... type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
.... description 0..1 markdown Description of the outcome
.... reference 0..1 Reference(EvidenceVariable) Structured outcome definition
... result Σ 0..* Reference(EvidenceReport | Citation | DiagnosticReport) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchStudy.label.​type Base extensible Title Type 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.phase Base required Research Study Phase Code 📦0.1.0 This IG
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍5.0.0 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍5.0.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 FHIR Std.
ResearchStudy.whyStopped Base example Research Study Reason Stopped 📍5.0.0 FHIR Std.
ResearchStudy.comparisonGroup.​type Base extensible Research Study Arm Type 📍5.0.0 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍5.0.0 FHIR Std.
ResearchStudy.outcomeMeasure.​type Base preferred Research Study Objective Type 📍5.0.0 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error 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()

This structure is derived from ResearchStudy

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron