NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: Research Study Subject

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject Version: 0.2.0
Draft as of 2023-06-12 Computable Name: ResearchStudySubject

A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions.

Usage:

Formal Views of Profile Content

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

This structure is derived from NcpiResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... partOf 1..1Reference(ResearchStudy)Part of larger study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... partOf Σ1..1Reference(ResearchStudy)Part of larger study
... 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn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 Σ1..1Reference(NCPI Study Group)Inclusion & exclusion criteria

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ResearchStudy.statusrequiredResearchStudyStatus

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... id Σ0..1idLogical 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): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... 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 Σ1..1Reference(ResearchStudy)Part of larger study
... 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.

... 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.


.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... 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 Σ1..1Reference(NCPI Study Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Research Consortium)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

Terminology Bindings

PathConformanceValueSet
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
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

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from NcpiResearchStudy

Summary

Mandatory: 3 elements

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from NcpiResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... partOf 1..1Reference(ResearchStudy)Part of larger study

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... partOf Σ1..1Reference(ResearchStudy)Part of larger study
... 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 Σ1..1Reference(NCPI Study Group)Inclusion & exclusion criteria

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ResearchStudy.statusrequiredResearchStudyStatus

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*NcpiResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... id Σ0..1idLogical 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): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... consent 1..1Reference(Research Study Consent)Research Study Subject Consent
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent
... 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 Σ1..1Reference(ResearchStudy)Part of larger study
... 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.

... 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.


.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: StudyCohort
..... display1..1stringRepresentation defined by the system
Fixed Value: Study Cohort
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... 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 Σ1..1Reference(NCPI Study Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Research Consortium)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

Terminology Bindings

PathConformanceValueSet
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
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

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from NcpiResearchStudy

Summary

Mandatory: 3 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron