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

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.

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element
Must-Support: 2 elements

Structures

This structure refers to these other structures:

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyCDMH ResearchStudy
... status S1..1codeactive | 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn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 S0..*Reference(CDMH Group)Inclusion & exclusion criteria

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyCDMH ResearchStudy
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!SΣ1..1codeactive | 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 Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ0..1CodeableConceptn-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 Σ0..*CodeableConceptClassifications for the study
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment SΣ0..*Reference(CDMH Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-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..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.


doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyCDMH ResearchStudy
... status ?!Σ1..1codeactive | 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 Σ0..*Reference(CDMH Group)Inclusion & exclusion criteria

doco 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:

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyCDMH ResearchStudy
... status S1..1codeactive | 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 S0..*Reference(CDMH Group)Inclusion & exclusion criteria

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyCDMH ResearchStudy
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!SΣ1..1codeactive | 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 Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.

... phase Σ0..1CodeableConceptn-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 Σ0..*CodeableConceptClassifications for the study
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ0..*CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1markdownWhat this is study doing
... enrollment SΣ0..*Reference(CDMH Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-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..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.


doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
ResearchStudy.languagepreferredCommonLanguages
Max Binding: AllLanguages
ResearchStudy.statusrequiredResearchStudyStatus
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
ResearchStudy.phaseexampleResearchStudyPhase
ResearchStudy.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
ResearchStudy.objective.typepreferredResearchStudyObjectiveType

Constraints

IdPathDetailsRequirements
dom-2ResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3ResearchStudyIf 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-4ResearchStudyIf 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-5ResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6ResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1ResearchStudy.metaAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.implicitRulesAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.languageAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.textAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.identifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.titleAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.protocolAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.partOfAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.statusAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.primaryPurposeTypeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.phaseAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.categoryAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.focusAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.conditionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.contactAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.relatedArtifactAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.keywordAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.locationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.descriptionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.enrollmentAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.periodAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.sponsorAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.principalInvestigatorAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.siteAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.reasonStoppedAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.noteAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.armAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.arm.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.arm.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.arm.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.arm.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.arm.nameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.arm.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.arm.descriptionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.objectiveAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.objective.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.objective.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.objective.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1ResearchStudy.objective.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.objective.nameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1ResearchStudy.objective.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())