FHIR for FAIR - FHIR Implementation Guide
0.1.0 - STU 1 Ballot

This page is part of the FHIR for FAIR - FHIR Implementation Guide (v0.1.0: STU 1 (FHIR R4b) Ballot 1) based on FHIR v4.1.0. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: ResearchStudy (Study Level Medatata)

Defining URL:http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/ResearchStudy-uv-f4f
Version:0.1.0
Name:ResearchStudyF4F
Title:ResearchStudy (Study Level Medatata)
Status:Active as of 12/5/21 12:01 AM
Definition:

This profile defines how to use the ResearchStudy resource to convey metadata information for a FAIR collection of data at the study level realized by using HL7 FHIR

Publisher:Health Level Seven International - SOA Work Group
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/ResearchStudy-uv-f4f

Formal Views of Profile Content

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

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... persistentUrl 0..1urlPersistent URL extension
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/persistentUrl
... copyright 0..1markdownCopyright and Licence
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
... identifier S0..*IdentifierBusiness Identifier for study
... title S0..1stringName for this study
... 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
... primaryPurposeType S0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... relatedArtifact S0..*RelatedArtifactF4FRelated artifacts for a knowledge resource
... description S0..1markdownWhat this is study doing
... objective S0..*BackboneElementA goal for the study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation 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)
Max Binding: AllLanguages: IETF language tag

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... persistentUrl 0..1urlPersistent URL extension
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/persistentUrl
... copyright 0..1markdownCopyright and Licence
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
... researchStudy-context 0..*UsageContextUsage Context (ResearchStudy)
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness Identifier for study
... title SΣ0..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 SΣ0..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 S0..*RelatedArtifactF4FRelated artifacts for a knowledge resource
... 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 S0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(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..1idUnique 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 S0..*BackboneElementA goal for the study
.... id 0..1idUnique 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..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this 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.

... relatedArtifact 0..*RelatedArtifactF4FRelated artifacts for a knowledge resource
... description 0..1markdownWhat this is study doing
... objective 0..*BackboneElementA goal for the study

doco Documentation for this format

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation to increase healthcare-related patient-independent knowledge
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... persistentUrl 0..1urlPersistent URL extension
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/persistentUrl
... copyright 0..1markdownCopyright and Licence
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
... identifier S0..*IdentifierBusiness Identifier for study
... title S0..1stringName for this study
... 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
... primaryPurposeType S0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... relatedArtifact S0..*RelatedArtifactF4FRelated artifacts for a knowledge resource
... description S0..1markdownWhat this is study doing
... objective S0..*BackboneElementA goal for the study

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..*ResearchStudyInvestigation 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)
Max Binding: AllLanguages: IETF language tag

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... persistentUrl 0..1urlPersistent URL extension
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/persistentUrl
... copyright 0..1markdownCopyright and Licence
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
... researchStudy-context 0..*UsageContextUsage Context (ResearchStudy)
URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness Identifier for study
... title SΣ0..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 SΣ0..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 S0..*RelatedArtifactF4FRelated artifacts for a knowledge resource
... 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 S0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(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..1idUnique 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 S0..*BackboneElementA goal for the study
.... id 0..1idUnique 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.exists() and ('#'+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(uri) = '#').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.extension:urlAll FHIR elements must have a @value or children unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
ext-1ResearchStudy.extension:urlMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.extension:copyrightAll FHIR elements must have a @value or children unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
ext-1ResearchStudy.extension:copyrightMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1ResearchStudy.extension:contextAll FHIR elements must have a @value or children unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
ext-1ResearchStudy.extension:contextMust 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 unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
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 unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
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 unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
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())