Extensions for Using Data Elements from FHIR R4B in FHIR R5
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR R5
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR R5 - Downloaded Version null See the Directory of published versions
| Official URL: http://hl7.org/fhir/4.3/StructureDefinition/profile-ResearchSubject | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 0 | Computable Name: Profile_R4B_ResearchSubject_R5 | ||
This cross-version profile allows R4B ResearchSubject content to be represented via FHIR R5 ResearchSubject resources.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
 status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. |
   Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |
   extension:status |
0..1 | code | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. Constraints: ext-1 | |
 study |
Σ | 1..1 | Reference(ResearchStudy) | Study subject is part of |
 subject |
Σ | 1..1 | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchSubject.implicitRules, ResearchSubject.modifierExtension, ResearchSubject.status, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.study, ResearchSubject.subject | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchSubject.modifierExtension, ResearchSubject.status.extension, ResearchSubject.status.extension:status | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |
 status |
||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:status |
0..1 | code | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |||||
| 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
| |||||
| 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 | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | ||||
| 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 | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. Constraints: ext-1 | |||||
| value |
0..1 | code | Primitive value for code | |||||
| progress |
0..* | BackboneElement | Subject status | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| type |
0..1 | CodeableConcept | state | milestone Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to. | |||||
| subjectState |
0..1 | CodeableConcept | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectState (required): Indicates the progression of a study subject through a study. | |||||
| milestone |
0..1 | CodeableConcept | SignedUp | Screened | Randomized Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones. | |||||
| reason |
0..1 | CodeableConcept | State change reason Binding: StateChangeReason (2.0.0) (example): Indicates why the state of the subject changed. | |||||
| startDate |
0..1 | dateTime | State change date | |||||
| endDate |
0..1 | dateTime | State change date | |||||
| period |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(ResearchStudy) | Study subject is part of | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study | ||||
| assignedComparisonGroup |
0..1 | id | What path should be followed | |||||
| actualComparisonGroup |
0..1 | id | What path was followed | |||||
| consent |
0..* | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| ResearchSubject.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.type | Base | example | Research Subject State Type | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.subjectState | Base | required | Research Subject State | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.milestone | Base | example | Research Subject Milestone | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.reason | Base | example | StateChangeReason | 📍2.0.0 | THO v7.1 |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchSubject.meta, ResearchSubject.implicitRules, ResearchSubject.language, ResearchSubject.text, ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.identifier, ResearchSubject.status, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.progress, ResearchSubject.progress.extension, ResearchSubject.progress.modifierExtension, ResearchSubject.progress.type, ResearchSubject.progress.subjectState, ResearchSubject.progress.milestone, ResearchSubject.progress.reason, ResearchSubject.progress.startDate, ResearchSubject.progress.endDate, ResearchSubject.period, ResearchSubject.study, ResearchSubject.subject, ResearchSubject.assignedComparisonGroup, ResearchSubject.actualComparisonGroup, ResearchSubject.consent | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.progress.extension, ResearchSubject.progress.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchSubject
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |
| extension:status |
0..1 | code | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. Constraints: ext-1 | |
| study |
Σ | 1..1 | Reference(ResearchStudy) | Study subject is part of |
| subject |
Σ | 1..1 | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchSubject.implicitRules, ResearchSubject.modifierExtension, ResearchSubject.status, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.study, ResearchSubject.subject | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchSubject.modifierExtension, ResearchSubject.status.extension, ResearchSubject.status.extension:status | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |
| status |
||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:status |
0..1 | code | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject(5.0.0) | Participant or object which is the recipient of investigative activities in a study | |||||
| 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
| |||||
| 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 | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | ||||
| 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 | R4B: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-ResearchSubject.status Binding: R4BResearchSubjectStatusForR5PublicationStatus (0.1.0) (required): Indicates the progression of a study subject through a study. Constraints: ext-1 | |||||
| value |
0..1 | code | Primitive value for code | |||||
| progress |
0..* | BackboneElement | Subject status | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| type |
0..1 | CodeableConcept | state | milestone Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to. | |||||
| subjectState |
0..1 | CodeableConcept | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectState (required): Indicates the progression of a study subject through a study. | |||||
| milestone |
0..1 | CodeableConcept | SignedUp | Screened | Randomized Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones. | |||||
| reason |
0..1 | CodeableConcept | State change reason Binding: StateChangeReason (2.0.0) (example): Indicates why the state of the subject changed. | |||||
| startDate |
0..1 | dateTime | State change date | |||||
| endDate |
0..1 | dateTime | State change date | |||||
| period |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(ResearchStudy) | Study subject is part of | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study | ||||
| assignedComparisonGroup |
0..1 | id | What path should be followed | |||||
| actualComparisonGroup |
0..1 | id | What path was followed | |||||
| consent |
0..* | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| ResearchSubject.status | Base | required | PublicationStatus | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.type | Base | example | Research Subject State Type | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.subjectState | Base | required | Research Subject State | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.milestone | Base | example | Research Subject Milestone | 📍5.0.0 | FHIR Std. |
| ResearchSubject.progress.reason | Base | example | StateChangeReason | 📍2.0.0 | THO v7.1 |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 | ResearchSubject | 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 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchSubject.meta, ResearchSubject.implicitRules, ResearchSubject.language, ResearchSubject.text, ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.identifier, ResearchSubject.status, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.progress, ResearchSubject.progress.extension, ResearchSubject.progress.modifierExtension, ResearchSubject.progress.type, ResearchSubject.progress.subjectState, ResearchSubject.progress.milestone, ResearchSubject.progress.reason, ResearchSubject.progress.startDate, ResearchSubject.progress.endDate, ResearchSubject.period, ResearchSubject.study, ResearchSubject.subject, ResearchSubject.assignedComparisonGroup, ResearchSubject.actualComparisonGroup, ResearchSubject.consent | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.status.extension, ResearchSubject.status.extension:status, ResearchSubject.progress.extension, ResearchSubject.progress.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchSubject
Other representations of profile: CSV, Excel, Schematron
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r4b.r5#0.1.0 based on FHIR 5.0.0. Generated 2026-03-20
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