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-researchstudy
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchStudy | I | 0..* | 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) 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 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 | SΣ | 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) |
| title | Σ | 0..1 | string | Name for this study |
| protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study |
| partOf | Σ | 0..* | 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) |
| primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible) |
| 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) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example) |
| condition | Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example) |
| 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) |
| location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible) |
| description | 0..1 | markdown | What this is study doing | |
| enrollment | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria |
| period | Σ | 0..1 | Period | When the study began and ended |
| sponsor | Σ | 0..1 | Reference(Organization) | 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) |
| note | 0..* | Annotation | Comments made about the study | |
| arm | I | 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 | I | 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) | |
| Documentation for this format | ||||
This structure is derived from ResearchStudy
Differential View
This structure is derived from ResearchStudy
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | I | 0..* | 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) 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 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 | SΣ | 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) |
| title | Σ | 0..1 | string | Name for this study |
| protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study |
| partOf | Σ | 0..* | 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) |
| primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible) |
| 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) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example) |
| condition | Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example) |
| 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) |
| location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible) |
| description | 0..1 | markdown | What this is study doing | |
| enrollment | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria |
| period | Σ | 0..1 | Period | When the study began and ended |
| sponsor | Σ | 0..1 | Reference(Organization) | 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) |
| note | 0..* | Annotation | Comments made about the study | |
| arm | I | 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 | I | 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) | |
| Documentation for this format | ||||
Other representations of profile: Schematron
| Path | Conformance | ValueSet |
| ResearchStudy.language | preferred | CommonLanguages Max Binding: AllLanguages |
| ResearchStudy.identifier.use | required | IdentifierUse |
| ResearchStudy.identifier.type | extensible | Identifier Type Codes |
| 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 |
| Id | Path | Details | Requirements |
| dom-2 | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-4 | 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-3 | 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-6 | ResearchStudy | A resource should have narrative for robust management : text.div.exists() | |
| dom-5 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| ele-1 | ResearchStudy.arm | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.objective | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
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.
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