Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.23 Resource ResearchSubject - Content

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

A physical entity which is the primary unit of operational and/or administrative interest in a study.

8.23.1 Scope and Usage

A research subject is the entity of interest in a research study, typically a human being or an animal, but can also be a device, group of humans or animals, or a tissue sample. The ResearchSubject resource describes essential information about the subject, including the gender, birthdate, study, study arm, consent status, and other key items. Human research subjects are usually not traceable to a particular person to protect the subject’s privacy.

The ResearchSubject resource is used in the following research activities:

  • Consent and registration to a research study
  • Exposure to test therapy
  • Assessment of test therapy results
  • Reporting of adverse events

8.23.2 References

No resources refer to this resource directly.

This resource does not implement any patterns.

8.23.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject TUDomainResourcePhysical entity which is the primary unit of interest in the 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectProgresss (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
... assignedArm 0..1stringWhat path should be followed
... actualArm 0..1stringWhat path was followed
... consent 0..1Reference(Consent)Agreement to participate in study

doco Documentation for this format

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 studyassignedArm : string [0..1]The name of the arm in the study the subject actually followed as part of this studyactualArm : string [0..1]A record of the patient's informed agreement to participate in the studyconsent : Reference [0..1] « 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)ResearchSubjectProgresss! »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>
 <assignedArm value="[string]"/><!-- 0..1 What path should be followed -->
 <actualArm value="[string]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..1 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.assignedArm [ string ]; # 0..1 What path should be followed
  fhir:ResearchSubject.actualArm [ string ]; # 0..1 What path was followed
  fhir:ResearchSubject.consent [ Reference(Consent) ]; # 0..1 Agreement to participate in study
]

Changes since R3

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|4.6.0
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.individual
  • 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

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject TUDomainResourcePhysical entity which is the primary unit of interest in the 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
ResearchSubjectProgresss (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
... assignedArm 0..1stringWhat path should be followed
... actualArm 0..1stringWhat path was followed
... consent 0..1Reference(Consent)Agreement to participate in study

doco Documentation for this format

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 studyassignedArm : string [0..1]The name of the arm in the study the subject actually followed as part of this studyactualArm : string [0..1]A record of the patient's informed agreement to participate in the studyconsent : Reference [0..1] « 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)ResearchSubjectProgresss! »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>
 <assignedArm value="[string]"/><!-- 0..1 What path should be followed -->
 <actualArm value="[string]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..1 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.assignedArm [ string ]; # 0..1 What path should be followed
  fhir:ResearchSubject.actualArm [ string ]; # 0..1 What path was followed
  fhir:ResearchSubject.consent [ Reference(Consent) ]; # 0..1 Agreement to participate in study
]

Changes since Release 3

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|4.6.0
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.individual
  • 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.)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

8.23.3.1 Terminology Bindings

PathDefinitionTypeReference
ResearchSubject.status RequiredPublicationStatus
ResearchSubject.progress.type ExampleResearchSubjectStateType
ResearchSubject.progress.subjectState Requiredhttp://hl7.org/fhir/ValueSet/research-subject-progress
ResearchSubject.progress.milestone ExampleResearchSubjectMilestone
ResearchSubject.progress.reason ExampleStateChangeReason

8.23.4 ResearchSubject State Machine

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

Diagram showing typical state machine for the ResearchSubject resource

8.23.5 Search Parameters

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)
status Ntokendraft | 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