FHIR CI-Build

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
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8.24 Resource ResearchSubject - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 0 Trial UseSecurity Category: Patient Compartments: Device, Patient

A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.

A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above.

The ResearchSubject resource describes information about the subject in the context of a research study.

Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject's privacy.

Note that in a human drug trial the human is the research subject even though the drug is what is being investigated.

The scope of ResearchSubject is intended to support the following use cases:

  • Humans and Animals for Clinical and Pre-clinical Trials
  • Drug Products for Stability Studies and other Tests
  • Devices for non-clinical laboratory studies - in-vivo and in-vitro
  • Tissue Sample for bench science studies

Structure

Name iconFlags iconCard. iconType iconDescription & Constraints icondoco icon
.. ResearchSubject TUDomainResourceParticipant or object which is the recipient of investigative activities in a study

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness Identifier for research subject in a study

... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... progress 0..*BackboneElementSubject status

.... type 0..1CodeableConceptstate | milestone
ResearchSubjectStateType (Example)
.... subjectState 0..1CodeableConceptcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectState (Required)
.... milestone 0..1CodeableConceptSignedUp | Screened | Randomized
ResearchSubjectMilestone (Example)
.... reason 0..1CodeableConceptState change reason
StateChangeReason (Example)
.... startDate 0..1dateTimeState change date
.... endDate 0..1dateTimeState change date
... study Σ1..1Reference(ResearchStudy)Study subject is part of
... subject Σ1..1Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct)Who or what is part of study
... assignedComparisonGroup 0..1idWhat path should be followed
... actualComparisonGroup 0..1idWhat path was followed
... consent 0..*Reference(Consent)Agreement to participate in study


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

ResearchSubject (DomainResource)Identifiers assigned to this research subject for a studyidentifier : Identifier [0..*]The publication state of the resource (not of the subject) (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The dates the subject began and ended their participation in the studyperiod : Period [0..1]Reference to the study the subject is participating instudy : Reference [1..1] « ResearchStudy »The record of the person, animal or other entity involved in the studysubject : Reference [1..1] « Patient|Group|Specimen|Device| Medication|Substance|BiologicallyDerivedProduct »The name of the arm in the study the subject is expected to follow as part of this studyassignedComparisonGroup : id [0..1]The name of the arm in the study the subject actually followed as part of this studyactualComparisonGroup : id [0..1]A record of the patient's informed agreement to participate in the studyconsent : Reference [0..*] « Consent »ProgressIdentifies the aspect of the subject's journey that the state refers totype : CodeableConcept [0..1] « null (Strength=Example)ResearchSubjectStateType?? »The current state of the subjectsubjectState : CodeableConcept [0..1] « null (Strength=Required)ResearchSubjectState! »The milestones the subject has passed throughmilestone : CodeableConcept [0..1] « null (Strength=Example)ResearchSubjectMilestone?? »The reason for the state change. If coded it should follow the formal subject state modelreason : CodeableConcept [0..1] « null (Strength=Example)StateChangeReason?? »The date when the new status startedstartDate : dateTime [0..1]The date when the state endedendDate : dateTime [0..1]The current state (status) of the subject and resons for status change where appropriateprogress[0..*]

XML Template

<ResearchSubject xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business Identifier for research subject in a study --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <progress>  <!-- 0..* Subject status -->
  <type><!-- 0..1 CodeableConcept state | milestone --></type>
  <subjectState><!-- 0..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn --></subjectState>
  <milestone><!-- 0..1 CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <reason><!-- 0..1 CodeableConcept State change reason --></reason>
  <startDate value="[dateTime]"/><!-- 0..1 State change date -->
  <endDate value="[dateTime]"/><!-- 0..1 State change date -->
 </progress>
 <period><!-- 0..1 Period Start and end of participation --></period>
 <study><!-- 1..1 Reference(ResearchStudy) Study subject is part of --></study>
 <subject><!-- 1..1 Reference(BiologicallyDerivedProduct|Device|Group|Medication|
   Patient|Specimen|Substance) Who or what is part of study --></subject>
 <assignedComparisonGroup value="[id]"/><!-- 0..1 What path should be followed -->
 <actualComparisonGroup value="[id]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..* Reference(Consent) Agreement to participate in study --></consent>
</ResearchSubject>

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ResearchSubject;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchSubject.identifier [ Identifier ], ... ; # 0..* Business Identifier for research subject in a study
  fhir:ResearchSubject.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ResearchSubject.progress [ # 0..* Subject status
    fhir:ResearchSubject.progress.type [ CodeableConcept ]; # 0..1 state | milestone
    fhir:ResearchSubject.progress.subjectState [ CodeableConcept ]; # 0..1 candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
    fhir:ResearchSubject.progress.milestone [ CodeableConcept ]; # 0..1 SignedUp | Screened | Randomized
    fhir:ResearchSubject.progress.reason [ CodeableConcept ]; # 0..1 State change reason
    fhir:ResearchSubject.progress.startDate [ dateTime ]; # 0..1 State change date
    fhir:ResearchSubject.progress.endDate [ dateTime ]; # 0..1 State change date
  ], ...;
  fhir:ResearchSubject.period [ Period ]; # 0..1 Start and end of participation
  fhir:ResearchSubject.study [ Reference(ResearchStudy) ]; # 1..1 Study subject is part of
  fhir:ResearchSubject.subject [ Reference(BiologicallyDerivedProduct|Device|Group|Medication|Patient|Specimen|Substance) ]; # 1..1 Who or what is part of study
  fhir:ResearchSubject.assignedComparisonGroup [ id ]; # 0..1 What path should be followed
  fhir:ResearchSubject.actualComparisonGroup [ id ]; # 0..1 What path was followed
  fhir:ResearchSubject.consent [ Reference(Consent) ], ... ; # 0..* Agreement to participate in study
]

Changes since R4

ResearchSubject
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
ResearchSubject.progress
  • Added Element
ResearchSubject.progress.type
  • Added Element
ResearchSubject.progress.subjectState
  • Added Element
ResearchSubject.progress.milestone
  • Added Element
ResearchSubject.progress.reason
  • Added Element
ResearchSubject.progress.startDate
  • Added Element
ResearchSubject.progress.endDate
  • Added Element
ResearchSubject.subject
  • Added Mandatory Element
ResearchSubject.assignedComparisonGroup
  • Added Element
ResearchSubject.actualComparisonGroup
  • Added Element
ResearchSubject.consent
  • Max Cardinality changed from 1 to *
  • Max Cardinality changed from 1 to *
ResearchSubject.individual
  • deleted
ResearchSubject.assignedArm
  • deleted
ResearchSubject.actualArm
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

Structure

Name iconFlags iconCard. iconType iconDescription & Constraints icondoco icon
.. ResearchSubject TUDomainResourceParticipant or object which is the recipient of investigative activities in a study

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness Identifier for research subject in a study

... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... progress 0..*BackboneElementSubject status

.... type 0..1CodeableConceptstate | milestone
ResearchSubjectStateType (Example)
.... subjectState 0..1CodeableConceptcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectState (Required)
.... milestone 0..1CodeableConceptSignedUp | Screened | Randomized
ResearchSubjectMilestone (Example)
.... reason 0..1CodeableConceptState change reason
StateChangeReason (Example)
.... startDate 0..1dateTimeState change date
.... endDate 0..1dateTimeState change date
... study Σ1..1Reference(ResearchStudy)Study subject is part of
... subject Σ1..1Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct)Who or what is part of study
... assignedComparisonGroup 0..1idWhat path should be followed
... actualComparisonGroup 0..1idWhat path was followed
... consent 0..*Reference(Consent)Agreement to participate in study


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

ResearchSubject (DomainResource)Identifiers assigned to this research subject for a studyidentifier : Identifier [0..*]The publication state of the resource (not of the subject) (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The dates the subject began and ended their participation in the studyperiod : Period [0..1]Reference to the study the subject is participating instudy : Reference [1..1] « ResearchStudy »The record of the person, animal or other entity involved in the studysubject : Reference [1..1] « Patient|Group|Specimen|Device| Medication|Substance|BiologicallyDerivedProduct »The name of the arm in the study the subject is expected to follow as part of this studyassignedComparisonGroup : id [0..1]The name of the arm in the study the subject actually followed as part of this studyactualComparisonGroup : id [0..1]A record of the patient's informed agreement to participate in the studyconsent : Reference [0..*] « Consent »ProgressIdentifies the aspect of the subject's journey that the state refers totype : CodeableConcept [0..1] « null (Strength=Example)ResearchSubjectStateType?? »The current state of the subjectsubjectState : CodeableConcept [0..1] « null (Strength=Required)ResearchSubjectState! »The milestones the subject has passed throughmilestone : CodeableConcept [0..1] « null (Strength=Example)ResearchSubjectMilestone?? »The reason for the state change. If coded it should follow the formal subject state modelreason : CodeableConcept [0..1] « null (Strength=Example)StateChangeReason?? »The date when the new status startedstartDate : dateTime [0..1]The date when the state endedendDate : dateTime [0..1]The current state (status) of the subject and resons for status change where appropriateprogress[0..*]

XML Template

<ResearchSubject xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business Identifier for research subject in a study --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <progress>  <!-- 0..* Subject status -->
  <type><!-- 0..1 CodeableConcept state | milestone --></type>
  <subjectState><!-- 0..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn --></subjectState>
  <milestone><!-- 0..1 CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <reason><!-- 0..1 CodeableConcept State change reason --></reason>
  <startDate value="[dateTime]"/><!-- 0..1 State change date -->
  <endDate value="[dateTime]"/><!-- 0..1 State change date -->
 </progress>
 <period><!-- 0..1 Period Start and end of participation --></period>
 <study><!-- 1..1 Reference(ResearchStudy) Study subject is part of --></study>
 <subject><!-- 1..1 Reference(BiologicallyDerivedProduct|Device|Group|Medication|
   Patient|Specimen|Substance) Who or what is part of study --></subject>
 <assignedComparisonGroup value="[id]"/><!-- 0..1 What path should be followed -->
 <actualComparisonGroup value="[id]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..* Reference(Consent) Agreement to participate in study --></consent>
</ResearchSubject>

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ResearchSubject;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchSubject.identifier [ Identifier ], ... ; # 0..* Business Identifier for research subject in a study
  fhir:ResearchSubject.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ResearchSubject.progress [ # 0..* Subject status
    fhir:ResearchSubject.progress.type [ CodeableConcept ]; # 0..1 state | milestone
    fhir:ResearchSubject.progress.subjectState [ CodeableConcept ]; # 0..1 candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
    fhir:ResearchSubject.progress.milestone [ CodeableConcept ]; # 0..1 SignedUp | Screened | Randomized
    fhir:ResearchSubject.progress.reason [ CodeableConcept ]; # 0..1 State change reason
    fhir:ResearchSubject.progress.startDate [ dateTime ]; # 0..1 State change date
    fhir:ResearchSubject.progress.endDate [ dateTime ]; # 0..1 State change date
  ], ...;
  fhir:ResearchSubject.period [ Period ]; # 0..1 Start and end of participation
  fhir:ResearchSubject.study [ Reference(ResearchStudy) ]; # 1..1 Study subject is part of
  fhir:ResearchSubject.subject [ Reference(BiologicallyDerivedProduct|Device|Group|Medication|Patient|Specimen|Substance) ]; # 1..1 Who or what is part of study
  fhir:ResearchSubject.assignedComparisonGroup [ id ]; # 0..1 What path should be followed
  fhir:ResearchSubject.actualComparisonGroup [ id ]; # 0..1 What path was followed
  fhir:ResearchSubject.consent [ Reference(Consent) ], ... ; # 0..* Agreement to participate in study
]

Changes since Release 4

ResearchSubject
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
ResearchSubject.progress
  • Added Element
ResearchSubject.progress.type
  • Added Element
ResearchSubject.progress.subjectState
  • Added Element
ResearchSubject.progress.milestone
  • Added Element
ResearchSubject.progress.reason
  • Added Element
ResearchSubject.progress.startDate
  • Added Element
ResearchSubject.progress.endDate
  • Added Element
ResearchSubject.subject
  • Added Mandatory Element
ResearchSubject.assignedComparisonGroup
  • Added Element
ResearchSubject.actualComparisonGroup
  • Added Element
ResearchSubject.consent
  • Max Cardinality changed from 1 to *
  • Max Cardinality changed from 1 to *
ResearchSubject.individual
  • deleted
ResearchSubject.assignedArm
  • deleted
ResearchSubject.actualArm
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

PathDefinitionTypeReference
ResearchSubject.status

The lifecycle status of an artifact.

RequiredPublicationStatus
ResearchSubject.progress.type

Identifies the kind of state being refered to.

ExampleResearchSubjectStateType
ResearchSubject.progress.subjectState

Indicates the progression of a study subject through a study.

RequiredResearchSubjectState
ResearchSubject.progress.milestone

Indicates the progression of a study subject through the study milestones.

ExampleResearchSubjectMilestone
ResearchSubject.progress.reason

Indicates why the state of the subject changed.

ExampleStateChangeReason

The following diagram reflects the "typical" state machine for ResearchSubject.

Diagram showing typical state machine for the ResearchSubject resource

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
datedateStart and end of participationResearchSubject.period
identifiertokenBusiness Identifier for research subject in a studyResearchSubject.identifier
patientreferenceWho or what is part of studyResearchSubject.subject
(Group, Specimen, BiologicallyDerivedProduct, Device, Medication, Patient, Substance)
statustokendraft | active | retired | unknownResearchSubject.status
studyreferenceStudy subject is part ofResearchSubject.study
(ResearchStudy)
subjectreferenceWho or what is part of studyResearchSubject.subject
(Group, Specimen, BiologicallyDerivedProduct, Device, Medication, Patient, Substance)
subject_statetokencandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawnResearchSubject.progress.subjectState