NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions
Resource Profile: Research Study Subject
| Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject | Version: 0.2.0 | |||
| Draft as of 2023-08-08 | Computable Name: ResearchStudySubject | |||
A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions. This profile is an R4 proxy for the more flexible R5 ResearchSubject.
Key Guidelines
The NCPI ResearchStudySubject profile represents the different access control restrictions that may be found within a given study. This profile links the consent usage restrictions with the related list of participants together within the study in which the participants are enrolled.
Added Profile Restrictions
Based on the NCPI Research Study profile, this resource:
- must have a partOf property which points to the main NcpiResearchStudy resource.
- should also use the Research Study Subject Consent extension to point to the corresponding consent resource.
Because it is derived from the NCPI Research Study profile, the resource’s enrollment must contain a single Study Group.
Usage:
- Examples for this Resource Profile: ResearchStudy/cmg-research-study-subject-cmg-hmb-irb-npu, ResearchStudy/cmg-research-study-subject-cmg-hmb-npu and ResearchStudy/ncpi-research-study-subject-01
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from NcpiResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchStudy | 0..* | NcpiResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
  extension | 1..* | Extension | Extension | |
 consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |
  partOf | 1..1 | Reference(ResearchStudy) | Part of larger study | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | NcpiResearchStudy | 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 | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| studyDesign | 0..* | CodeableConcept | Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example) | |
| consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
 partOf | Σ | 1..1 | 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. |
| enrollment | Σ | 1..1 | Reference(NCPI Study Group) | Inclusion & exclusion criteria |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| ResearchStudy.status | required | ResearchStudyStatus |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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().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(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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy | 0..* | NcpiResearchStudy | 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): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| studyDesign | 0..* | CodeableConcept | Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example) | |||||
| consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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 | 1..1 | 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. | ||||
| 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: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
 id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
 system | 1..1 | uri | Identity of the terminology system Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: StudyCohort | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Cohort | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions. | ||||
| 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: (unbound) (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 | 1..1 | Reference(NCPI Study Group) | Inclusion & exclusion criteria | ||||
| period | Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor | Σ | 0..1 | Reference(Research Consortium) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator | Σ | 0..1 | Reference(Practitioner) | Researcher who oversees multiple aspects of the study | ||||
| site | Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| 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 | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| 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 | |||||
| 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. | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| ResearchStudy.status | required | ResearchStudyStatus | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType | ||||
| ResearchStudy.phase | example | ResearchStudyPhase | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSet | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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 NcpiResearchStudy
Differential View
This structure is derived from NcpiResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | NcpiResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| extension | 1..* | Extension | Extension | |
| consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |
| partOf | 1..1 | Reference(ResearchStudy) | Part of larger study | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | NcpiResearchStudy | 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 | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| studyDesign | 0..* | CodeableConcept | Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example) | |
| consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| partOf | Σ | 1..1 | 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. |
| enrollment | Σ | 1..1 | Reference(NCPI Study Group) | Inclusion & exclusion criteria |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet |
| ResearchStudy.status | required | ResearchStudyStatus |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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().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(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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy | 0..* | NcpiResearchStudy | 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): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| studyDesign | 0..* | CodeableConcept | Research Study Design URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design Binding: Study Design (example) | |||||
| consent | 1..1 | Reference(Research Study Consent) | Research Study Subject Consent URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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 | 1..1 | 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. | ||||
| 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: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: StudyCohort | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Cohort | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions. | ||||
| 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: (unbound) (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 | 1..1 | Reference(NCPI Study Group) | Inclusion & exclusion criteria | ||||
| period | Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor | Σ | 0..1 | Reference(Research Consortium) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator | Σ | 0..1 | Reference(Practitioner) | Researcher who oversees multiple aspects of the study | ||||
| site | Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| 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 | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| 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 | |||||
| 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. | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| ResearchStudy.status | required | ResearchStudyStatus | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType | ||||
| ResearchStudy.phase | example | ResearchStudyPhase | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSet | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| 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 NcpiResearchStudy
Other representations of profile: CSV, Excel, Schematron