Release 5 R6 Ballot (1st Draft)

This page is part of the FHIR Specification (v5.0.0: R5 - STU v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes ). This is the The current published version in it's permanent home (it will always be available at this URL). is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.25 Resource ResearchSubject - Content

Biomedical Research and Regulation icon Work Group Maturity Level : 0   Trial Use Security Category : Patient Compartments : Device , Patient

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

8.25.1 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

8.25.2 References to this Resource

Resource References: AdverseEvent

No references for this Resource.

8.25.3 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 )
. . . progress 0..* BackboneElement Subject status

. . . . type 0..1 CodeableConcept state | milestone
Binding: Research Subject State Type ( Example )
. . . . 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
Binding: Research Subject State ( Required )
. . . . milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone ( Example )
. . . . reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason icon ( Example )
. . . . startDate 0..1 dateTime State change date
. . . . endDate 0..1 dateTime State change date
. . . study Σ 1..1 Reference ( ResearchStudy ) Study subject is part of
. . . subject Σ 1..1 Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct ) Who or what is part of study
. . . 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 study identifier : 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 study period : Period [0..1] Reference to the study the subject is participating in study : Reference [1..1] « ResearchStudy » The record of the person, animal or other entity involved in the study subject : 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 study assignedComparisonGroup : id [0..1] The name of the arm in the study the subject actually followed as part of this study actualComparisonGroup : id [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..*] « Consent » Progress Identifies the aspect of the subject's journey that the state refers to type : CodeableConcept [0..1] « null (Strength=Example) ResearchSubjectStateType ?? » The current state of the subject subjectState : CodeableConcept [0..1] « null (Strength=Required) ResearchSubjectState ! » The milestones the subject has passed through milestone : CodeableConcept [0..1] « null (Strength=Example) ResearchSubjectMilestone ?? » The reason for the state change. If coded it should follow the formal subject state model reason : CodeableConcept [0..1] « null (Strength=Example) StateChangeReason ?? » The date when the new status started startDate : dateTime [0..1] The date when the state ended endDate : dateTime [0..1] The current state (status) of the subject and resons for status change where appropriate progress [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>

  <reason><!-- 0..1 CodeableConcept State change reason icon --></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:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for research subject in a study
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:progress ( [ # 0..* Subject status
    fhir:type [ CodeableConcept ] ; # 0..1 state | milestone
    fhir: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:milestone [ CodeableConcept ] ; # 0..1 SignedUp | Screened | Randomized
    fhir:reason [ CodeableConcept ] ; # 0..1 State change reason
    fhir:startDate [ dateTime ] ; # 0..1 State change date
    fhir:endDate [ dateTime ] ; # 0..1 State change date
  ] ... ) ;
  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: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.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 *
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 .

See R4 <--> R5 Conversion Maps (status = See Conversions Summary .)

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 )
. . . progress 0..* BackboneElement Subject status

. . . . type 0..1 CodeableConcept state | milestone
Binding: Research Subject State Type ( Example )
. . . . 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
Binding: Research Subject State ( Required )
. . . . milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone ( Example )
. . . . reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason icon ( Example )
. . . . startDate 0..1 dateTime State change date
. . . . endDate 0..1 dateTime State change date
. . . study Σ 1..1 Reference ( ResearchStudy ) Study subject is part of
. . . subject Σ 1..1 Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct ) Who or what is part of study
. . . 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 study identifier : 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 study period : Period [0..1] Reference to the study the subject is participating in study : Reference [1..1] « ResearchStudy » The record of the person, animal or other entity involved in the study subject : 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 study assignedComparisonGroup : id [0..1] The name of the arm in the study the subject actually followed as part of this study actualComparisonGroup : id [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..*] « Consent » Progress Identifies the aspect of the subject's journey that the state refers to type : CodeableConcept [0..1] « null (Strength=Example) ResearchSubjectStateType ?? » The current state of the subject subjectState : CodeableConcept [0..1] « null (Strength=Required) ResearchSubjectState ! » The milestones the subject has passed through milestone : CodeableConcept [0..1] « null (Strength=Example) ResearchSubjectMilestone ?? » The reason for the state change. If coded it should follow the formal subject state model reason : CodeableConcept [0..1] « null (Strength=Example) StateChangeReason ?? » The date when the new status started startDate : dateTime [0..1] The date when the state ended endDate : dateTime [0..1] The current state (status) of the subject and resons for status change where appropriate progress [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>

  <reason><!-- 0..1 CodeableConcept State change reason icon --></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:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for research subject in a study
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:progress ( [ # 0..* Subject status
    fhir:type [ CodeableConcept ] ; # 0..1 state | milestone
    fhir: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:milestone [ CodeableConcept ] ; # 0..1 SignedUp | Screened | Randomized
    fhir:reason [ CodeableConcept ] ; # 0..1 State change reason
    fhir:startDate [ dateTime ] ; # 0..1 State change date
    fhir:endDate [ dateTime ] ; # 0..1 State change date
  ] ... ) ;
  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: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.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 *
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 .

See R4 <--> R5 Conversion Maps (status = See Conversions Summary .)

 

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

8.25.3.1 Terminology Bindings

Path ValueSet Type Documentation
ResearchSubject.status PublicationStatus Required

The lifecycle status of an artifact.

ResearchSubject.progress.type ResearchSubjectStateType Example

Identifies the kind of state being refered to.

ResearchSubject.progress.subjectState ResearchSubjectState Required

Indicates the progression of a study subject through a study.

ResearchSubject.progress.milestone ResearchSubjectMilestone Example

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

ResearchSubject.progress.reason StateChangeReason icon Example

Indicates why the state of the subject changed.

8.25.4 ResearchSubject State Machine

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

Diagram showing typical state machine for the ResearchSubject resource

8.25.5 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 27 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 ) 		66 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 | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn ResearchSubject.progress.subjectState