Common Data Models Harmonization
1.0.0 - STU 1 Publication

Publication Build: This will be filled in by the publication tooling

## Resource Profile: CdmhResearchStudy

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

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Text Summary
- Differential Table
- Snapshot Table
- Snapshot Table (Must Support)
- All

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element
Must-Support: 2 elements

Structures

This structure refers to these other structures:

- CDMH Group (http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-group)

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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn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 | ?!S 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.
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 | S Σ | 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

Summary

Mandatory: 1 element
Must-Support: 2 elements

Structures

This structure refers to these other structures:

- CDMH Group (http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-group)

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 | ?!S 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.
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 | S Σ | 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

#### 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.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()) |