Standard Health Record FHIR Implementation Guide

SHR Study Profile

 

The official URL for this profile is:

http://standardhealthrecord.org/fhir/StructureDefinition/shr-research-Study

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 ResearchStudy.

This profile was published on Wed Dec 20 00:00:00 EST 2017 as a draft by The MITRE Corporation: Standard Health Record Collaborative.

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

Summary

Mandatory: 0 element (2 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

SHR Mapping Source

This structure represents the following SHR mapping definition:

shr.research.Study maps to ResearchStudy:
  Title maps to title
  Identifier maps to identifier
  PartOf maps to partOf
  Status maps to status
  Enrollment maps to enrollment
  EffectiveTimePeriod maps to period
  Sponsor maps to sponsor
  Jurisdiction maps to jurisdiction
  ContactDetail maps to contact
  PrincipalInvestigator maps to principalInvestigator
  Facility maps to site
  TerminationReason maps to reasonStopped
  Annotation maps to note
  StudyArm.Title maps to arm.name
  StudyArm.Type maps to arm.code
  StudyArm.Details maps to arm.description

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy I0..*SHR Study Profile
... 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: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Author-extension 0..1(Complex)SHR Author Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Author-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-entity-Type-extension 0..1CodeableConceptSHR Type Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-entity-Type-extension
... shr-core-Details-extension 0..1stringSHR Details Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-core-Details-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..1SHR Identifier ProfileBusiness Identifier for study
... title Σ1..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(SHR Study Profile)Part of larger study
... status ?!Σ1..1codedraft | in-progress | suspended | stopped | completed | entered-in-error
Binding: ResearchStudyStatus (required)
... category Σ0..*CodeableConceptClassifications for the study
Binding: (unbound) (example)
... focus Σ0..*CodeableConceptDrugs, devices, conditions, etc. under study
Binding: (unbound) (example)
... contact Σ0..*SHR ContactDetail ProfileContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example)
... jurisdiction Σ0..1CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible)
... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(SHR Group Profile)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(SHR Organization Profile)Organization responsible for the study
... principalInvestigator Σ0..1Reference(SHR Practitioner Profile)The individual responsible for the study
... site Σ0..*Reference(SHR Facility Profile)Location involved in study execution
... reasonStopped Σ0..1CodeableConceptReason for terminating study early
... note 0..*SHR Annotation ProfileComments made about the event
... arm I0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... name 1..1stringLabel for study arm
.... code 0..1CodeableConceptCategorization of study arm
Binding: SHR StudyArmTypeVS ValueSet (required)
.... description 0..1stringShort explanation of study path

doco Documentation for this format

Summary

Mandatory: 0 element (2 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

SHR Mapping Source

This structure represents the following SHR mapping definition:

shr.research.Study maps to ResearchStudy:
  Title maps to title
  Identifier maps to identifier
  PartOf maps to partOf
  Status maps to status
  Enrollment maps to enrollment
  EffectiveTimePeriod maps to period
  Sponsor maps to sponsor
  Jurisdiction maps to jurisdiction
  ContactDetail maps to contact
  PrincipalInvestigator maps to principalInvestigator
  Facility maps to site
  TerminationReason maps to reasonStopped
  Annotation maps to note
  StudyArm.Title maps to arm.name
  StudyArm.Type maps to arm.code
  StudyArm.Details maps to arm.description

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy I0..*SHR Study Profile
... 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: Common Languages (extensible)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... shr-base-RelatedEncounter-extension 0..1Reference(SHR EncounterPerformed Profile)SHR RelatedEncounter Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-RelatedEncounter-extension
... shr-base-Author-extension 0..1(Complex)SHR Author Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Author-extension
... shr-base-Informant-extension 0..1(Complex)SHR Informant Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-base-Informant-extension
... shr-entity-Type-extension 0..1CodeableConceptSHR Type Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-entity-Type-extension
... shr-core-Details-extension 0..1stringSHR Details Extension
URL: http://standardhealthrecord.org/fhir/StructureDefinition/shr-core-Details-extension
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..1SHR Identifier ProfileBusiness Identifier for study
... title Σ1..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(SHR Study Profile)Part of larger study
... status ?!Σ1..1codedraft | in-progress | suspended | stopped | completed | entered-in-error
Binding: ResearchStudyStatus (required)
... category Σ0..*CodeableConceptClassifications for the study
Binding: (unbound) (example)
... focus Σ0..*CodeableConceptDrugs, devices, conditions, etc. under study
Binding: (unbound) (example)
... contact Σ0..*SHR ContactDetail ProfileContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: (unbound) (example)
... jurisdiction Σ0..1CodeableConceptGeographic region(s) for study
Binding: Jurisdiction ValueSet (extensible)
... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(SHR Group Profile)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(SHR Organization Profile)Organization responsible for the study
... principalInvestigator Σ0..1Reference(SHR Practitioner Profile)The individual responsible for the study
... site Σ0..*Reference(SHR Facility Profile)Location involved in study execution
... reasonStopped Σ0..1CodeableConceptReason for terminating study early
... note 0..*SHR Annotation ProfileComments made about the event
... arm I0..*BackboneElementDefined path through the study for a subject
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
.... name 1..1stringLabel for study arm
.... code 0..1CodeableConceptCategorization of study arm
Binding: SHR StudyArmTypeVS ValueSet (required)
.... description 0..1stringShort explanation of study path

doco Documentation for this format

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

 

Terminology Bindings

PathNameConformanceValueSet
ResearchStudy.languageCommon LanguagesextensibleCommon Languages
ResearchStudy.statusResearchStudyStatusrequiredResearchStudyStatus
ResearchStudy.category?extexample
ResearchStudy.focus?extexample
ResearchStudy.keyword?extexample
ResearchStudy.jurisdictionJurisdiction ValueSetextensibleJurisdiction ValueSet
ResearchStudy.arm.codeSHR StudyArmTypeVS ValueSetrequiredSHR StudyArmTypeVS ValueSet

 

Constraints

IdPathDetailsRequirements
dom-2ResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-1ResearchStudyIf the resource is contained in another resource, it SHALL NOT contain any narrative
: contained.text.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-3ResearchStudyIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
: contained.where(('#'+id in %resource.descendants().reference).not()).empty()
ele-1ResearchStudy.armAll FHIR elements must have a @value or children
: hasValue() | (children().count() > id.count())