Research Data Sharing IG
1.0.0 - CI Build International flag

Research Data Sharing IG, published by IEHR-Workgroup. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/InteropEHRate-project/research-data-sharing/ and changes regularly. See the Directory of published versions

Resource Profile: ResearchStudy - IEHR

Official URL: http://interopehrate.eu/fhir/StructureDefinition/ResearchStudy-IEHR Version: 1.0.0
Draft as of 2024-04-08 Computable Name: ResearchStudyIEHR

Usage:

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..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... language 1..1 code Language of the resource content
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... identifier 1..* Identifier Business Identifier for study
... title 1..1 string Name for this study
... primaryPurposeType 1..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... contact 1..* ContactDetail Contact details for the study
... location 1..* CodeableConcept Geographic region(s) for study
... description 0..1 markdown What this is study doing
... enrollment 1..* Reference(Cohort) Inclusion & exclusion criteria
... period 1..1 Period When the study began and ended
... site 1..* Reference(ResearchLocation) Facility where study activities are conducted

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... DataSetDefinition 1..1 (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/DataSetDefinitionExtension-IEHR
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier for study
... title Σ 1..1 string Name for this study
... 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.

... primaryPurposeType Σ 1..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.

... contact Σ 1..* ContactDetail Contact details for the study
... location Σ 1..* 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 Σ 1..* Reference(Cohort) Inclusion & exclusion criteria
... period Σ 1..1 Period When the study began and ended
... site Σ 1..* Reference(ResearchLocation) Facility where study activities are conducted

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard

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()
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).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..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... id Σ 0..1 id 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 1..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... DataSetDefinition 1..1 (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/DataSetDefinitionExtension-IEHR
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier for study
... title Σ 1..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 ?!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 1..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 1..* 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 1..* 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 Σ 1..* Reference(Cohort) Inclusion & exclusion criteria
... period Σ 1..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 1..* Reference(ResearchLocation) 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.phaseexampleResearchStudyPhase
http://hl7.org/fhir/ValueSet/research-study-phase
from the FHIR Standard
ResearchStudy.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

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()
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).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()

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... language 1..1 code Language of the resource content
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... identifier 1..* Identifier Business Identifier for study
... title 1..1 string Name for this study
... primaryPurposeType 1..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... contact 1..* ContactDetail Contact details for the study
... location 1..* CodeableConcept Geographic region(s) for study
... description 0..1 markdown What this is study doing
... enrollment 1..* Reference(Cohort) Inclusion & exclusion criteria
... period 1..1 Period When the study began and ended
... site 1..* Reference(ResearchLocation) Facility where study activities are conducted

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... DataSetDefinition 1..1 (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/DataSetDefinitionExtension-IEHR
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier for study
... title Σ 1..1 string Name for this study
... 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.

... primaryPurposeType Σ 1..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.

... contact Σ 1..* ContactDetail Contact details for the study
... location Σ 1..* 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 Σ 1..* Reference(Cohort) Inclusion & exclusion criteria
... period Σ 1..1 Period When the study began and ended
... site Σ 1..* Reference(ResearchLocation) Facility where study activities are conducted

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard

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()
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).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..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-7: Either ResearchStudy.description or a PDF with documentation must be provided
... id Σ 0..1 id 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 1..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 1..1 NarrativeIEHR Human-readable summary of the resource (essential clinical and business information)
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... DataSetDefinition 1..1 (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/DataSetDefinitionExtension-IEHR
... RDDQuestionnaire 0..* (Complex) Extension
URL: http://interopehrate.eu/fhir/StructureDefinition/QuestionnaireExtension-IEHR
... EnrollmentPeriod 1..1 Period Enrollment Period
URL: http://interopehrate.eu/fhir/StructureDefinition/EnrollmentPeriodExtension-IEHR
... RequestedAnonymizationType 0..1 Coding Anonymization Type
URL: http://interopehrate.eu/fhir/StructureDefinition/AnonymizationExtension-IEHR
Binding: Anonymization ValueSet (extensible)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier for study
... title Σ 1..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 ?!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 1..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 1..* 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 1..* 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 Σ 1..* Reference(Cohort) Inclusion & exclusion criteria
... period Σ 1..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 1..* Reference(ResearchLocation) 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.phaseexampleResearchStudyPhase
http://hl7.org/fhir/ValueSet/research-study-phase
from the FHIR Standard
ResearchStudy.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

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()
dom-7errorResearchStudyEither ResearchStudy.description or a PDF with documentation must be provided
: description.exists() or relatedArtifact.where(type = 'documentation' and document.where(contentType = 'application/pdf' and data.exists()).exists()).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()

 

Other representations of profile: CSV, Excel, Schematron