Research Data Sharing IG
1.0.0 - CI Build
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
Official URL: http://interopehrate.eu/fhir/StructureDefinition/ResearchStudy-IEHR | Version: 1.0.0 | |||
Draft as of 2024-04-08 | Computable Name: ResearchStudyIEHR |
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
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) | |
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 | |
Documentation for this format |
Id | Grade | Path(s) | Details | Requirements |
dom-7 | error | ResearchStudy | Either 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() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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 | |||||
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 | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
dom-7 | error | ResearchStudy | Either 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-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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. | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard | ||||
ResearchStudy.category | example | |||||
ResearchStudy.focus | example | |||||
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard | ||||
ResearchStudy.keyword | example | |||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | ||||
ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard | ||||
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
dom-7 | error | ResearchStudy | Either 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-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ResearchStudy
Summary
Mandatory: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from ResearchStudy
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
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) | |
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 | |
Documentation for this format |
Id | Grade | Path(s) | Details | Requirements |
dom-7 | error | ResearchStudy | Either 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
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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 | |||||
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 | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
dom-7 | error | ResearchStudy | Either 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-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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. | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard | ||||
ResearchStudy.category | example | |||||
ResearchStudy.focus | example | |||||
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard | ||||
ResearchStudy.keyword | example | |||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | ||||
ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard | ||||
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management : text.`div`.exists() | |
dom-7 | error | ResearchStudy | Either 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-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ResearchStudy
Summary
Mandatory: 12 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron