Clinical Research Core Implementation Guide 0.3 - Continuous Build
The official URL for this profile is:
https://esource-consortium.github.io/fhir-clinical-research/cr-core-researchsubject
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchSubject
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchSubject | I | 0..* | Physical entity which is the primary unit of interest in the 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: CommonLanguages (preferred) Max Binding: AllLanguages | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
 contained | 0..* | Resource | Contained, inline Resources | |
 extension | 0..* | Extension | Additional content defined by implementations | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 0..* | Identifier | Business Identifier for research subject in a study |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | SΣ | 0..1 | uri | The namespace for the identifier value Example General': http://www.acme.com/identifiers/patient |
| value | Σ | 0..1 | string | The value that is unique Example General': 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
  assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| status | ?!Σ | 1..1 | code | 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required) |
| period | Σ | 0..1 | Period | Start and end of participation |
| study | SΣ | 1..1 | Reference(CRCoreResearchStudy) | Study subject is part of |
| individual | SΣ | 1..1 | Reference(CRCorePatient) | Who is part of study |
| assignedArm | 0..1 | string | What path should be followed | |
| actualArm | 0..1 | string | What path was followed | |
| consent | 0..1 | Reference(Consent) | Agreement to participate in study | |
| Documentation for this format | ||||
This structure is derived from ResearchSubject
Differential View
This structure is derived from ResearchSubject
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject | I | 0..* | Physical entity which is the primary unit of interest in the 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: CommonLanguages (preferred) Max Binding: AllLanguages | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 0..* | Identifier | Business Identifier for research subject in a study |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | SΣ | 0..1 | uri | The namespace for the identifier value Example General': http://www.acme.com/identifiers/patient |
| value | Σ | 0..1 | string | The value that is unique Example General': 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| status | ?!Σ | 1..1 | code | 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: ResearchSubjectStatus (required) |
| period | Σ | 0..1 | Period | Start and end of participation |
| study | SΣ | 1..1 | Reference(CRCoreResearchStudy) | Study subject is part of |
| individual | SΣ | 1..1 | Reference(CRCorePatient) | Who is part of study |
| assignedArm | 0..1 | string | What path should be followed | |
| actualArm | 0..1 | string | What path was followed | |
| consent | 0..1 | Reference(Consent) | Agreement to participate in study | |
| Documentation for this format | ||||
Other representations of profile: Schematron
| Path | Conformance | ValueSet |
| ResearchSubject.language | preferred | CommonLanguages Max Binding: AllLanguages |
| ResearchSubject.identifier.use | required | IdentifierUse |
| ResearchSubject.identifier.type | extensible | Identifier Type Codes |
| ResearchSubject.status | required | ResearchSubjectStatus |
| Id | Path | Details | Requirements |
| dom-2 | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-4 | 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-3 | 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().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-6 | ResearchSubject | A resource should have narrative for robust management : text.div.exists() | |
| dom-5 | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
CR Core Implementation Guide © 2018+ Clinical Research Core Implementation Guide. Based on FHIR version (4.0.0). IG generated on Thu, Jun 20, 2019 11:42-0400.
Links: Table of Contents |
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