INTEROPen CareConnect Base STU3 Implementation Guide - Local Development build (v3.0.0). See the Directory of published versions
StructureDefinition: CareConnect-ResearchStudy-1
A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.
The official URL for this profile is:
https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
Summary
Structures
This structure refers to these other structures:
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Location-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Patient-1
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchStudy | I | 0..* | ResearchStudy | 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: Common Languages (extensible) Max Binding: All Languages | |
| text | I | 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 | Σ | 0..* | Identifier | Business Identifier for study |
 id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | Σ | 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(CareConnect-Organization-1) | 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(CareConnect-ResearchStudy-1) | Part of larger study |
| status | ?!Σ | 1..1 | code | draft | in-progress | suspended | stopped | completed | entered-in-error Binding: ResearchStudyStatus (required) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, conditions, etc. under study Binding: (unbound) (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) |
| jurisdiction | 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(CareConnect-Organization-1) | Organization responsible for the study |
| principalInvestigator | Σ | 0..1 | Reference(CareConnect-Practitioner-1) | The individual responsible for the study |
| site | Σ | 0..* | Reference(CareConnect-Location-1) | Location involved in study execution |
| reasonStopped | Σ | 0..1 | CodeableConcept | Reason for terminating study early |
| note | 0..* | Annotation | Comments made about the event | |
| id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
 author[x] | Σ | 0..1 | Individual responsible for the annotation | |
| authorString | string | |||
| authorReference | Reference(CareConnect-Patient-1 | CareConnect-Practitioner-1 | CareConnect-RelatedPerson-1) | |||
| time | Σ | 0..1 | dateTime | When the annotation was made |
| text | 1..1 | string | The annotation - text content | |
 arm | I | 0..* | BackboneElement | Defined path through the study for a subject |
 id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | 1..1 | string | Label for study arm | |
| code | 0..1 | CodeableConcept | Categorization of study arm | |
| description | 0..1 | string | Short explanation of study path | |
| Documentation for this format | ||||
This structure is derived from ResearchStudy
Summary
Structures
This structure refers to these other structures:
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Location-1
- https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Patient-1
Differential View
This structure is derived from ResearchStudy
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | I | 0..* | ResearchStudy | 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: Common Languages (extensible) Max Binding: All Languages | |
| text | I | 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 | Σ | 0..* | Identifier | Business Identifier for study |
| id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary (If known) Binding: IdentifierUse (required) |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) |
| system | Σ | 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(CareConnect-Organization-1) | 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(CareConnect-ResearchStudy-1) | Part of larger study |
| status | ?!Σ | 1..1 | code | draft | in-progress | suspended | stopped | completed | entered-in-error Binding: ResearchStudyStatus (required) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, conditions, etc. under study Binding: (unbound) (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) |
| jurisdiction | 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(CareConnect-Organization-1) | Organization responsible for the study |
| principalInvestigator | Σ | 0..1 | Reference(CareConnect-Practitioner-1) | The individual responsible for the study |
| site | Σ | 0..* | Reference(CareConnect-Location-1) | Location involved in study execution |
| reasonStopped | Σ | 0..1 | CodeableConcept | Reason for terminating study early |
| note | 0..* | Annotation | Comments made about the event | |
| id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| author[x] | Σ | 0..1 | Individual responsible for the annotation | |
| authorString | string | |||
| authorReference | Reference(CareConnect-Patient-1 | CareConnect-Practitioner-1 | CareConnect-RelatedPerson-1) | |||
| time | Σ | 0..1 | dateTime | When the annotation was made |
| text | 1..1 | string | The annotation - text content | |
| arm | I | 0..* | BackboneElement | Defined path through the study for a subject |
| id | 0..1 | string | xml:id (or equivalent in JSON) | |
| extension | 0..* | Extension | Additional Content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | 1..1 | string | Label for study arm | |
| code | 0..1 | CodeableConcept | Categorization of study arm | |
| description | 0..1 | string | Short explanation of study path | |
| Documentation for this format | ||||
Other representations of profile: Schematron
Terminology Bindings
Terminology Bindings
| Path | Conformance | ValueSet |
| ResearchStudy.language | extensible | Common Languages Max Binding: All Languages |
| ResearchStudy.identifier.use | required | IdentifierUse |
| ResearchStudy.identifier.type | extensible | Identifier Type Codes |
| ResearchStudy.status | required | ResearchStudyStatus |
| ResearchStudy.category | example | |
| ResearchStudy.focus | example | |
| ResearchStudy.keyword | example | |
| ResearchStudy.jurisdiction | extensible | Jurisdiction ValueSet |
Constraints
Constraints
| 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-1 | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain any narrative : contained.text.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 : contained.where(('#'+id in %resource.descendants().reference).not()).empty() | |
| ele-1 | ResearchStudy.arm | All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count()) |