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8.26 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.



8.26.1 Scope and Usage

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

The Subject State is the research subject's (participant’s) movement through the study protocol from the subject's point of view. The Subject Milestone is how the study activities relate to the subject's movement through the study protocol. The two are separate. State is driven by the subject and the Milestone is driven by the study protocol. The values in each element may be the same if necessary for study reasons.

8.26.2 References to this Resource

8.26.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject TU DomainResource Participant 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 Σ 0..* Identifier Business Identifier for research subject in a study

... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... period Σ 0..1 Period Start and end of participation
... subject Σ 1..1 Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) Who or what is part of study
... subjectState 0..* BackboneElement A duration in the lifecycle of the ResearchSubject within a ResearchStudy

.... code 1..1 CodeableConcept candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
Binding: Research Subject State (Extensible)
.... startDate 1..1 dateTime The date a research subject entered the given state
.... endDate 0..1 dateTime The date a research subject exited or left the given state
.... reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason icon (Example)
... subjectMilestone 0..* BackboneElement A significant event in the progress of a ResearchSubject

.... milestone 1..* CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone (Extensible)

.... date 0..1 dateTime The date/time when this milestone event was completed
.... reason 0..1 CodeableConcept
... assignedComparisonGroup 0..1 id What path should be followed
... actualComparisonGroup 0..1 id What 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 »SubjectStateIdentifies the aspect of the subject's journey that the state refers tocode : CodeableConcept [1..1] « null (Strength=Extensible)ResearchSubjectState+ »The date a research subject entered the given statestartDate : dateTime [1..1]The date a research subject exited or left the given stateendDate : dateTime [0..1]The reason for the state change. If coded it should follow the formal subject state modelreason : CodeableConcept [0..1] « null (Strength=Example)StateChangeReason?? »SubjectMilestoneA specific event in the research subjects journey through a research studymilestone : CodeableConcept [1..*] « null (Strength=Extensible)ResearchSubjectMilestone+ »The date/time when this milestone event was completeddate : dateTime [0..1]A rationale that provides additional clarification for the milestone that was captured or documentedreason : CodeableConcept [0..1]A duration in the lifecycle of the ResearchSubject within a ResearchStudysubjectState[0..*]A significant event in the progress of a ResearchSubjectsubjectMilestone[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 -->
 <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>
 <subjectState>  <!-- 0..* A duration in the lifecycle of the ResearchSubject within a ResearchStudy -->
  <code><!-- 1..1 CodeableConcept candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study --></code>
  <startDate value="[dateTime]"/><!-- 1..1 The date a research subject entered the given state -->
  <endDate value="[dateTime]"/><!-- 0..1 The date a research subject exited or left the given state -->
  <reason><!-- 0..1 CodeableConcept State change reason icon --></reason>
 </subjectState>
 <subjectMilestone>  <!-- 0..* A significant event in the progress of a ResearchSubject -->
  <milestone><!-- 1..* CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <date value="[dateTime]"/><!-- 0..1 The date/time when this milestone event was completed -->
  <reason><!-- 0..1 CodeableConcept  --></reason>
 </subjectMilestone>
 <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>

JSON Template

{doco
  "resourceType" : "ResearchSubject",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for research subject in a study
  "status" : "<code>", // R!  draft | active | retired | unknown
  "period" : { Period }, // Start and end of participation
  "study" : { Reference(ResearchStudy) }, // R!  Study subject is part of
  "subject" : { Reference(BiologicallyDerivedProduct|Device|Group|Medication|
   Patient|Specimen|Substance) }, // R!  Who or what is part of study
  "subjectState" : [{ // A duration in the lifecycle of the ResearchSubject within a ResearchStudy
    "code" : { CodeableConcept }, // R!  candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
    "startDate" : "<dateTime>", // R!  The date a research subject entered the given state
    "endDate" : "<dateTime>", // The date a research subject exited or left the given state
    "reason" : { CodeableConcept } // State change reason icon
  }],
  "subjectMilestone" : [{ // A significant event in the progress of a ResearchSubject
    "milestone" : [{ CodeableConcept }], // R!  SignedUp | Screened | Randomized
    "date" : "<dateTime>", // The date/time when this milestone event was completed
    "reason" : { CodeableConcept } // 
  }],
  "assignedComparisonGroup" : "<id>", // What path should be followed
  "actualComparisonGroup" : "<id>", // What path was followed
  "consent" : [{ Reference(Consent) }] // Agreement to participate in study
}

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:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for research subject in a study
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:period [ Period ] ; # 0..1 Start and end of participation
  fhir:study [ Reference(ResearchStudy) ] ; # 1..1 Study subject is part of
  fhir:subject [ Reference(BiologicallyDerivedProduct|Device|Group|Medication|Patient|Specimen|Substance) ] ; # 1..1 Who or what is part of study
  fhir:subjectState ( [ # 0..* A duration in the lifecycle of the ResearchSubject within a ResearchStudy
    fhir:code [ CodeableConcept ] ; # 1..1 candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
    fhir:startDate [ dateTime ] ; # 1..1 The date a research subject entered the given state
    fhir:endDate [ dateTime ] ; # 0..1 The date a research subject exited or left the given state
    fhir:reason [ CodeableConcept ] ; # 0..1 State change reason
  ] ... ) ;
  fhir:subjectMilestone ( [ # 0..* A significant event in the progress of a ResearchSubject
    fhir:milestone  ( [ CodeableConcept ] ... ) ; # 1..* SignedUp | Screened | Randomized
    fhir:date [ dateTime ] ; # 0..1 The date/time when this milestone event was completed
    fhir:reason [ CodeableConcept ] ; # 0..1 
  ] ... ) ;
  fhir:assignedComparisonGroup [ id ] ; # 0..1 What path should be followed
  fhir:actualComparisonGroup [ id ] ; # 0..1 What path was followed
  fhir:consent  ( [ Reference(Consent) ] ... ) ; # 0..* Agreement to participate in study
]

Changes from both R4 and R4B

ResearchSubject
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to PublicationStatus
  • Remove codes candidate, eligible, follow-up, ineligible, not-registered, off-study, on-study, on-study-intervention, on-study-observation, pending-on-study, potential-candidate, screening, withdrawn
  • Add codes draft, active, retired, unknown
ResearchSubject.subject
  • Added Mandatory Element
ResearchSubject.subjectState
  • Added Element
ResearchSubject.subjectState.code
  • Added Mandatory Element
ResearchSubject.subjectState.startDate
  • Added Mandatory Element
ResearchSubject.subjectState.endDate
  • Added Element
ResearchSubject.subjectState.reason
  • Added Element
ResearchSubject.subjectMilestone
  • Added Element
ResearchSubject.subjectMilestone.milestone
  • Added Mandatory Element
ResearchSubject.subjectMilestone.date
  • Added Element
ResearchSubject.subjectMilestone.reason
  • Added Element
ResearchSubject.assignedComparisonGroup
  • Added Element
ResearchSubject.actualComparisonGroup
  • Added Element
ResearchSubject.consent
  • 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 for R4 as XML or JSON and for R4B as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject TU DomainResource Participant 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 Σ 0..* Identifier Business Identifier for research subject in a study

... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... period Σ 0..1 Period Start and end of participation
... subject Σ 1..1 Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) Who or what is part of study
... subjectState 0..* BackboneElement A duration in the lifecycle of the ResearchSubject within a ResearchStudy

.... code 1..1 CodeableConcept candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
Binding: Research Subject State (Extensible)
.... startDate 1..1 dateTime The date a research subject entered the given state
.... endDate 0..1 dateTime The date a research subject exited or left the given state
.... reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason icon (Example)
... subjectMilestone 0..* BackboneElement A significant event in the progress of a ResearchSubject

.... milestone 1..* CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone (Extensible)

.... date 0..1 dateTime The date/time when this milestone event was completed
.... reason 0..1 CodeableConcept
... assignedComparisonGroup 0..1 id What path should be followed
... actualComparisonGroup 0..1 id What 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 »SubjectStateIdentifies the aspect of the subject's journey that the state refers tocode : CodeableConcept [1..1] « null (Strength=Extensible)ResearchSubjectState+ »The date a research subject entered the given statestartDate : dateTime [1..1]The date a research subject exited or left the given stateendDate : dateTime [0..1]The reason for the state change. If coded it should follow the formal subject state modelreason : CodeableConcept [0..1] « null (Strength=Example)StateChangeReason?? »SubjectMilestoneA specific event in the research subjects journey through a research studymilestone : CodeableConcept [1..*] « null (Strength=Extensible)ResearchSubjectMilestone+ »The date/time when this milestone event was completeddate : dateTime [0..1]A rationale that provides additional clarification for the milestone that was captured or documentedreason : CodeableConcept [0..1]A duration in the lifecycle of the ResearchSubject within a ResearchStudysubjectState[0..*]A significant event in the progress of a ResearchSubjectsubjectMilestone[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 -->
 <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>
 <subjectState>  <!-- 0..* A duration in the lifecycle of the ResearchSubject within a ResearchStudy -->
  <code><!-- 1..1 CodeableConcept candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study --></code>
  <startDate value="[dateTime]"/><!-- 1..1 The date a research subject entered the given state -->
  <endDate value="[dateTime]"/><!-- 0..1 The date a research subject exited or left the given state -->
  <reason><!-- 0..1 CodeableConcept State change reason icon --></reason>
 </subjectState>
 <subjectMilestone>  <!-- 0..* A significant event in the progress of a ResearchSubject -->
  <milestone><!-- 1..* CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <date value="[dateTime]"/><!-- 0..1 The date/time when this milestone event was completed -->
  <reason><!-- 0..1 CodeableConcept  --></reason>
 </subjectMilestone>
 <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>

JSON Template

{doco
  "resourceType" : "ResearchSubject",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for research subject in a study
  "status" : "<code>", // R!  draft | active | retired | unknown
  "period" : { Period }, // Start and end of participation
  "study" : { Reference(ResearchStudy) }, // R!  Study subject is part of
  "subject" : { Reference(BiologicallyDerivedProduct|Device|Group|Medication|
   Patient|Specimen|Substance) }, // R!  Who or what is part of study
  "subjectState" : [{ // A duration in the lifecycle of the ResearchSubject within a ResearchStudy
    "code" : { CodeableConcept }, // R!  candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
    "startDate" : "<dateTime>", // R!  The date a research subject entered the given state
    "endDate" : "<dateTime>", // The date a research subject exited or left the given state
    "reason" : { CodeableConcept } // State change reason icon
  }],
  "subjectMilestone" : [{ // A significant event in the progress of a ResearchSubject
    "milestone" : [{ CodeableConcept }], // R!  SignedUp | Screened | Randomized
    "date" : "<dateTime>", // The date/time when this milestone event was completed
    "reason" : { CodeableConcept } // 
  }],
  "assignedComparisonGroup" : "<id>", // What path should be followed
  "actualComparisonGroup" : "<id>", // What path was followed
  "consent" : [{ Reference(Consent) }] // Agreement to participate in study
}

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:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for research subject in a study
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:period [ Period ] ; # 0..1 Start and end of participation
  fhir:study [ Reference(ResearchStudy) ] ; # 1..1 Study subject is part of
  fhir:subject [ Reference(BiologicallyDerivedProduct|Device|Group|Medication|Patient|Specimen|Substance) ] ; # 1..1 Who or what is part of study
  fhir:subjectState ( [ # 0..* A duration in the lifecycle of the ResearchSubject within a ResearchStudy
    fhir:code [ CodeableConcept ] ; # 1..1 candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
    fhir:startDate [ dateTime ] ; # 1..1 The date a research subject entered the given state
    fhir:endDate [ dateTime ] ; # 0..1 The date a research subject exited or left the given state
    fhir:reason [ CodeableConcept ] ; # 0..1 State change reason
  ] ... ) ;
  fhir:subjectMilestone ( [ # 0..* A significant event in the progress of a ResearchSubject
    fhir:milestone  ( [ CodeableConcept ] ... ) ; # 1..* SignedUp | Screened | Randomized
    fhir:date [ dateTime ] ; # 0..1 The date/time when this milestone event was completed
    fhir:reason [ CodeableConcept ] ; # 0..1 
  ] ... ) ;
  fhir:assignedComparisonGroup [ id ] ; # 0..1 What path should be followed
  fhir:actualComparisonGroup [ id ] ; # 0..1 What path was followed
  fhir:consent  ( [ Reference(Consent) ] ... ) ; # 0..* Agreement to participate in study
]

Changes from both R4 and R4B

ResearchSubject
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to PublicationStatus
  • Remove codes candidate, eligible, follow-up, ineligible, not-registered, off-study, on-study, on-study-intervention, on-study-observation, pending-on-study, potential-candidate, screening, withdrawn
  • Add codes draft, active, retired, unknown
ResearchSubject.subject
  • Added Mandatory Element
ResearchSubject.subjectState
  • Added Element
ResearchSubject.subjectState.code
  • Added Mandatory Element
ResearchSubject.subjectState.startDate
  • Added Mandatory Element
ResearchSubject.subjectState.endDate
  • Added Element
ResearchSubject.subjectState.reason
  • Added Element
ResearchSubject.subjectMilestone
  • Added Element
ResearchSubject.subjectMilestone.milestone
  • Added Mandatory Element
ResearchSubject.subjectMilestone.date
  • Added Element
ResearchSubject.subjectMilestone.reason
  • Added Element
ResearchSubject.assignedComparisonGroup
  • Added Element
ResearchSubject.actualComparisonGroup
  • Added Element
ResearchSubject.consent
  • 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 for R4 as XML or JSON and for R4B as XML or JSON.

 

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

8.26.3.1 Terminology Bindings

Path ValueSet Type Documentation
ResearchSubject.status PublicationStatus Required

The lifecycle status of an artifact.
ResearchSubject.subjectState.code ResearchSubjectState Extensible

Indicates the progression of a study subject through a study.
ResearchSubject.subjectState.reason StateChangeReason icon Example

Indicates why the state of the subject changed.
ResearchSubject.subjectMilestone.milestone ResearchSubjectMilestone Extensible

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



8.26.4 ResearchSubject State Machine

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

Diagram showing typical state machine for the ResearchSubject resource

8.26.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
date date Start and end of participation ResearchSubject.period 26 Resources
identifier token Business Identifier for research subject in a study ResearchSubject.identifier 65 Resources
patient reference Who or what is part of study ResearchSubject.subject.where(resolve() is Patient)
(Patient)		 65 Resources
status token draft | active | retired | unknown ResearchSubject.status
study reference Study subject is part of ResearchSubject.study
(ResearchStudy)
subject reference Who or what is part of study ResearchSubject.subject
(Group, Specimen, BiologicallyDerivedProduct, Device, Medication, Patient, Substance)
subject_state token candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study ResearchSubject.subjectState.code