Common Data Models Harmonization
1.0.0 - STU 1 Publication
Common Data Models Harmonization
1.0.0 - STU 1 Publication
Common Data Models Harmonization, published by HL7 International - Biomedical Research and Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/cdmh/ and changes regularly. See the Directory of published versions
| Defining URL: | http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-researchstudy |
| Version: | 1.0.0 |
| Name: | CdmhResearchStudy |
| Title: | CDMH ResearchStudy |
| Status: | Draft as of 9/1/19 |
| Definition: | This is the ResearchStudy Resource profile for the IG. |
| Publisher: | HL7 International - Biomedical Research and Regulation Work Group |
| Copyright: | Used by permission of HL7, all rights reserved Creative Commons License |
| Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-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 | 0..* | ResearchStudy | CDMH ResearchStudy | |
  status | S | 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn |
  enrollment | S | 0..* | Reference(CDMH Group) | Inclusion & exclusion criteria |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | CDMH ResearchStudy | |
 id | Σ | 0..1 | string | 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: A human language. | |
| 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 | 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 | 0..* | Reference(ResearchStudy) | Part of larger study |
| status | ?!SΣ | 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. |
| 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 | SΣ | 0..* | Reference(CDMH 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): 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 | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | CDMH ResearchStudy | |
| 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 | 0..* | Reference(CDMH Group) | Inclusion & exclusion criteria |
| 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 | CDMH ResearchStudy | |
| status | S | 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 |
| enrollment | S | 0..* | Reference(CDMH Group) | Inclusion & exclusion criteria |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | CDMH ResearchStudy | |
| id | Σ | 0..1 | string | 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: A human language. | |
| 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 | 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 | 0..* | Reference(ResearchStudy) | Part of larger study |
| status | ?!SΣ | 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. |
| 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 | SΣ | 0..* | Reference(CDMH 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): 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 | ||||
Other representations of profile: CSV, Excel, Schematron
| 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 |
| 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.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()) |
IG © 2019+ HL7 International - Biomedical Research and Regulation Work Group. Package hl7.fhir.us.cdmh#1.0.0 based on FHIR 4.0.1. Generated 2021-12-06
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