HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.0

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ResearchStudy

 

The official URL for this profile is:

http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-ResearchStudy

A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

This profile builds on Basic.

This profile was published on Wed Apr 17 00:00:00 EDT 2019 as a draft by The MITRE Corporation.

Summary

Mandatory: 0 element (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Mapping Source

This structure represents the following mapping definition:

shr.core.ResearchStudy maps to Basic:
  _Entry.EntryId maps to id
  Language maps to language
  Narrative maps to text
  ImplicitRules maps to implicitRules
  Metadata.VersionId maps to meta.versionId
  Metadata.Profile maps to meta.profile
  Metadata.LastUpdated maps to meta.lastUpdated
  Metadata.SecurityLabel maps to meta.security
  Metadata.Tag maps to meta.tag

NameFlagsCard.TypeDescription & Constraintsdoco
.. Basic Σshr-core-ResearchStudy
... extension 3..*Slice: Unordered, Open by value:url
... shr-core-Status-extension 1..1CodeableConceptStatus
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension
.... valueCodeableConcept Binding: research-study-status (required)
... shr-core-Identifier-extension 1..1IdentifierIdentifier
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Identifier-extension
... shr-core-PartOf-extension 0..1Reference(shr-core-DomainResource)PartOf
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension
.... valueReference Reference(shr-core-ResearchStudy)ResearchStudy
... shr-core-Title-extension 1..1stringTitle
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Title-extension
... shr-core-CommentOrDescription-extension 0..1stringCommentOrDescription
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-CommentOrDescription-extension
... shr-core-Enrollment-extension 0..*Reference(shr-core-Group)Enrollment
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Enrollment-extension
... shr-core-EffectiveTimePeriod-extension 0..1PeriodEffectiveTimePeriod
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-EffectiveTimePeriod-extension
... shr-core-Sponsor-extension 0..1Reference(shr-core-Organization)Sponsor
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Sponsor-extension
... shr-core-Jurisdiction-extension 0..1CodeableConceptJurisdiction
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Jurisdiction-extension
Binding: jurisdiction (extensible)
... shr-core-ContactDetail-extension 0..*(Complex)ContactDetail
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-ContactDetail-extension
... shr-core-PrincipalInvestigator-extension 0..1Reference(shr-core-Practitioner)PrincipalInvestigator
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PrincipalInvestigator-extension
... shr-core-Location-extension 0..*Reference(shr-core-Location)Location
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Location-extension
... shr-core-TerminationReason-extension 0..1CodeableConceptTerminationReason
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-TerminationReason-extension
... shr-core-Annotation-extension 0..*AnnotationAnnotation
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Annotation-extension
... shr-core-StudyArm-extension 0..*(Complex)StudyArm
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-StudyArm-extension
... code Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/shr/CodeSystem/mcode-basic-resource-type","code":"shr-core-ResearchStudy","userSelected":false}]}

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Basic Σ0..*shr-core-ResearchStudy
... 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: http://tools.ietf.org/html/bcp47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 3..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
... shr-core-Status-extension 1..1CodeableConceptStatus
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension
.... id 0..1stringxml:id (or equivalent in JSON)
.... url 1..1uri"http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension"
.... valueCodeableConcept 1..1CodeableConceptValue of extension
Binding: research-study-status (required)
... shr-core-Identifier-extension 1..1IdentifierIdentifier
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Identifier-extension
... shr-core-PartOf-extension 0..1Reference(shr-core-DomainResource)PartOf
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension
.... id 0..1stringxml:id (or equivalent in JSON)
.... url 1..1uri"http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension"
.... valueReference 1..1Reference(shr-core-ResearchStudy)ResearchStudy
... shr-core-Title-extension 1..1stringTitle
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Title-extension
... shr-core-CommentOrDescription-extension 0..1stringCommentOrDescription
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-CommentOrDescription-extension
... shr-core-Enrollment-extension 0..*Reference(shr-core-Group)Enrollment
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Enrollment-extension
... shr-core-EffectiveTimePeriod-extension 0..1PeriodEffectiveTimePeriod
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-EffectiveTimePeriod-extension
... shr-core-Sponsor-extension 0..1Reference(shr-core-Organization)Sponsor
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Sponsor-extension
... shr-core-Jurisdiction-extension 0..1CodeableConceptJurisdiction
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Jurisdiction-extension
Binding: jurisdiction (extensible)
... shr-core-ContactDetail-extension 0..*(Complex)ContactDetail
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-ContactDetail-extension
... shr-core-PrincipalInvestigator-extension 0..1Reference(shr-core-Practitioner)PrincipalInvestigator
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PrincipalInvestigator-extension
... shr-core-Location-extension 0..*Reference(shr-core-Location)Location
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Location-extension
... shr-core-TerminationReason-extension 0..1CodeableConceptTerminationReason
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-TerminationReason-extension
... shr-core-Annotation-extension 0..*AnnotationAnnotation
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Annotation-extension
... shr-core-StudyArm-extension 0..*(Complex)StudyArm
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-StudyArm-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier
... code ?!Σ1..1CodeableConceptKind of Resource
Binding: Basic Resource Types (example)
Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/shr/CodeSystem/mcode-basic-resource-type","code":"shr-core-ResearchStudy","userSelected":false}]}
... subject Σ0..1Reference(Resource)Identifies the focus of this resource
... author Σ0..1Reference(Practitioner | Patient | RelatedPerson)Who created
... created Σ0..1dateWhen created

doco Documentation for this format

Summary

Mandatory: 0 element (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Mapping Source

This structure represents the following mapping definition:

shr.core.ResearchStudy maps to Basic:
  _Entry.EntryId maps to id
  Language maps to language
  Narrative maps to text
  ImplicitRules maps to implicitRules
  Metadata.VersionId maps to meta.versionId
  Metadata.Profile maps to meta.profile
  Metadata.LastUpdated maps to meta.lastUpdated
  Metadata.SecurityLabel maps to meta.security
  Metadata.Tag maps to meta.tag

Differential View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Basic Σshr-core-ResearchStudy
... extension 3..*Slice: Unordered, Open by value:url
... shr-core-Status-extension 1..1CodeableConceptStatus
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension
.... valueCodeableConcept Binding: research-study-status (required)
... shr-core-Identifier-extension 1..1IdentifierIdentifier
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Identifier-extension
... shr-core-PartOf-extension 0..1Reference(shr-core-DomainResource)PartOf
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension
.... valueReference Reference(shr-core-ResearchStudy)ResearchStudy
... shr-core-Title-extension 1..1stringTitle
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Title-extension
... shr-core-CommentOrDescription-extension 0..1stringCommentOrDescription
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-CommentOrDescription-extension
... shr-core-Enrollment-extension 0..*Reference(shr-core-Group)Enrollment
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Enrollment-extension
... shr-core-EffectiveTimePeriod-extension 0..1PeriodEffectiveTimePeriod
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-EffectiveTimePeriod-extension
... shr-core-Sponsor-extension 0..1Reference(shr-core-Organization)Sponsor
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Sponsor-extension
... shr-core-Jurisdiction-extension 0..1CodeableConceptJurisdiction
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Jurisdiction-extension
Binding: jurisdiction (extensible)
... shr-core-ContactDetail-extension 0..*(Complex)ContactDetail
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-ContactDetail-extension
... shr-core-PrincipalInvestigator-extension 0..1Reference(shr-core-Practitioner)PrincipalInvestigator
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PrincipalInvestigator-extension
... shr-core-Location-extension 0..*Reference(shr-core-Location)Location
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Location-extension
... shr-core-TerminationReason-extension 0..1CodeableConceptTerminationReason
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-TerminationReason-extension
... shr-core-Annotation-extension 0..*AnnotationAnnotation
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Annotation-extension
... shr-core-StudyArm-extension 0..*(Complex)StudyArm
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-StudyArm-extension
... code Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/shr/CodeSystem/mcode-basic-resource-type","code":"shr-core-ResearchStudy","userSelected":false}]}

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Basic Σ0..*shr-core-ResearchStudy
... 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: http://tools.ietf.org/html/bcp47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 3..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
... shr-core-Status-extension 1..1CodeableConceptStatus
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension
.... id 0..1stringxml:id (or equivalent in JSON)
.... url 1..1uri"http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Status-extension"
.... valueCodeableConcept 1..1CodeableConceptValue of extension
Binding: research-study-status (required)
... shr-core-Identifier-extension 1..1IdentifierIdentifier
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Identifier-extension
... shr-core-PartOf-extension 0..1Reference(shr-core-DomainResource)PartOf
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension
.... id 0..1stringxml:id (or equivalent in JSON)
.... url 1..1uri"http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PartOf-extension"
.... valueReference 1..1Reference(shr-core-ResearchStudy)ResearchStudy
... shr-core-Title-extension 1..1stringTitle
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Title-extension
... shr-core-CommentOrDescription-extension 0..1stringCommentOrDescription
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-CommentOrDescription-extension
... shr-core-Enrollment-extension 0..*Reference(shr-core-Group)Enrollment
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Enrollment-extension
... shr-core-EffectiveTimePeriod-extension 0..1PeriodEffectiveTimePeriod
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-EffectiveTimePeriod-extension
... shr-core-Sponsor-extension 0..1Reference(shr-core-Organization)Sponsor
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Sponsor-extension
... shr-core-Jurisdiction-extension 0..1CodeableConceptJurisdiction
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Jurisdiction-extension
Binding: jurisdiction (extensible)
... shr-core-ContactDetail-extension 0..*(Complex)ContactDetail
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-ContactDetail-extension
... shr-core-PrincipalInvestigator-extension 0..1Reference(shr-core-Practitioner)PrincipalInvestigator
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-PrincipalInvestigator-extension
... shr-core-Location-extension 0..*Reference(shr-core-Location)Location
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Location-extension
... shr-core-TerminationReason-extension 0..1CodeableConceptTerminationReason
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-TerminationReason-extension
... shr-core-Annotation-extension 0..*AnnotationAnnotation
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-Annotation-extension
... shr-core-StudyArm-extension 0..*(Complex)StudyArm
URL: http://hl7.org/fhir/us/shr/StructureDefinition/shr-core-StudyArm-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier
... code ?!Σ1..1CodeableConceptKind of Resource
Binding: Basic Resource Types (example)
Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/shr/CodeSystem/mcode-basic-resource-type","code":"shr-core-ResearchStudy","userSelected":false}]}
... subject Σ0..1Reference(Resource)Identifies the focus of this resource
... author Σ0..1Reference(Practitioner | Patient | RelatedPerson)Who created
... created Σ0..1dateWhen created

doco Documentation for this format

Downloads: StructureDefinition: (XML, JSON, TTL), Schema: XML Schematron

 

 

Constraints

IdPathDetailsRequirements