Kids First Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
Resource Profile: kfdrc-research-study
The official URL for this profile is:
http://fhir.kids-first.io/StructureDefinition/kfdrc-research-study
Formal Views of Profile Content
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 | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
  extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 display-name | S | 0..1 | string | Display name of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/display-name |
 related-organization | S | 0..* | (Complex) | Governing body of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/related-organization |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | I | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge |
 id | Σ | 0..1 | string | Logical id of this artifact |
 meta | ΣI | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!ΣI | 0..1 | uri | A set of rules under which this content was created |
| language | I | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages |
| text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | I | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
| display-name | SI | 0..1 | string | Display name of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/display-name |
| related-organization | SI | 0..* | (Complex) | Governing body of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/related-organization |
 modifierExtension | ?!I | 0..* | Extension | Extensions that cannot be ignored |
| identifier | ΣI | 0..* | Identifier | Business Identifier for study |
| title | ΣI | 0..1 | string | Name for this study |
 protocol | ΣI | 0..* | Reference(PlanDefinition) | Steps followed in executing study |
| partOf | ΣI | 0..* | Reference(ResearchStudy) | Part of larger study |
| status | ?!ΣI | 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 | ΣI | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible) |
| phase | ΣI | 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 | ΣI | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | ΣI | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example) |
| condition | ΣI | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example) |
| contact | ΣI | 0..* | ContactDetail | Contact details for the study |
| relatedArtifact | I | 0..* | RelatedArtifact | References and dependencies |
| keyword | ΣI | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example) |
| location | ΣI | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible) |
| description | I | 0..1 | markdown | What this is study doing |
| enrollment | ΣI | 0..* | Reference(Group) | Inclusion & exclusion criteria |
| period | ΣI | 0..1 | Period | When the study began and ended |
| sponsor | ΣI | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study |
| principalInvestigator | ΣI | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study |
| site | ΣI | 0..* | Reference(Location) | Facility where study activities are conducted |
| reasonStopped | ΣI | 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 | I | 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 | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | I | 1..1 | string | Label for study arm |
| type | I | 0..1 | CodeableConcept | Categorization of study arm |
| description | I | 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 | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | I | 0..1 | string | Label for the objective |
| type | I | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred) |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | I | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge |
| display-name | I | 0..1 | string | Display name of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/display-name |
| related-organization | I | 0..* | (Complex) | Governing body of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/related-organization |
| Documentation for this format | ||||
This structure is derived from ResearchStudy
Differential View
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| display-name | S | 0..1 | string | Display name of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/display-name |
| related-organization | S | 0..* | (Complex) | Governing body of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/related-organization |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | I | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | ΣI | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!ΣI | 0..1 | uri | A set of rules under which this content was created |
| language | I | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages |
| text | I | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | I | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
| display-name | SI | 0..1 | string | Display name of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/display-name |
| related-organization | SI | 0..* | (Complex) | Governing body of the Kids First DRC ResearchStudy URL: http://fhir.kids-first.io/StructureDefinition/related-organization |
| modifierExtension | ?!I | 0..* | Extension | Extensions that cannot be ignored |
| identifier | ΣI | 0..* | Identifier | Business Identifier for study |
| title | ΣI | 0..1 | string | Name for this study |
| protocol | ΣI | 0..* | Reference(PlanDefinition) | Steps followed in executing study |
| partOf | ΣI | 0..* | Reference(ResearchStudy) | Part of larger study |
| status | ?!ΣI | 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 | ΣI | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible) |
| phase | ΣI | 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 | ΣI | 0..* | CodeableConcept | Classifications for the study Binding: (unbound) (example) |
| focus | ΣI | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example) |
| condition | ΣI | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example) |
| contact | ΣI | 0..* | ContactDetail | Contact details for the study |
| relatedArtifact | I | 0..* | RelatedArtifact | References and dependencies |
| keyword | ΣI | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example) |
| location | ΣI | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible) |
| description | I | 0..1 | markdown | What this is study doing |
| enrollment | ΣI | 0..* | Reference(Group) | Inclusion & exclusion criteria |
| period | ΣI | 0..1 | Period | When the study began and ended |
| sponsor | ΣI | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study |
| principalInvestigator | ΣI | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study |
| site | ΣI | 0..* | Reference(Location) | Facility where study activities are conducted |
| reasonStopped | ΣI | 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 | I | 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 | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | I | 1..1 | string | Label for study arm |
| type | I | 0..1 | CodeableConcept | Categorization of study arm |
| description | I | 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 | I | 0..* | Extension | Additional content defined by implementations |
| modifierExtension | ?!ΣI | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | I | 0..1 | string | Label for the objective |
| type | I | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred) |
| Documentation for this format | ||||
Other representations of profile: Schematron
Terminology Bindings
| Path | Conformance | ValueSet |
| ResearchStudy.language | preferred | CommonLanguages Max Binding: AllLanguages |
| 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 | Path | Details | Requirements |
| dom-2 | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.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-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-5 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | ResearchStudy.meta | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.implicitRules | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.language | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.text | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.extension:display-name | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.extension:display-name | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.extension:related-organization | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.extension:related-organization | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.identifier | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.title | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.protocol | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.partOf | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.status | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.primaryPurposeType | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.phase | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.category | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.focus | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.condition | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.contact | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.relatedArtifact | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.keyword | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.location | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.description | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.enrollment | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.period | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.sponsor | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.principalInvestigator | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.site | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.reasonStopped | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.note | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.arm | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.arm.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.arm.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.arm.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.arm.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.arm.name | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.arm.type | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.arm.description | 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()) | |
| ele-1 | ResearchStudy.objective.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.objective.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.objective.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | ResearchStudy.objective.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | ResearchStudy.objective.name | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | ResearchStudy.objective.type | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |