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 2023-06-12 | Computable Name: ResearchStudySubject | |||
A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions.
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 | |
  Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
 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 | |
| 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.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 | |||||
| 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 | PractitionerRole) | 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 | |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| 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 | |
| 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 | |||||
| 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 | PractitionerRole) | 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