Release 4B R5 Final QA

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-draft-final: Final QA Preview for R5 - STU 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 8.25 Resource ResearchSubject - Content

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

A physical entity ResearchSubject is a participant or object which is the primary unit recipient of operational and/or administrative interest investigative activities in a research study.

8.23.1 8.25.1 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 drug product or animals, 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 essential information about the subject, including subject in the gender, birthdate, study, study arm, consent status, and other key items. context of a research study.

Human research subjects are usually not traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject’s 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 resource is used in intended to support the following research activities: use cases:

  • Consent Humans and registration to a research study Animals for Clinical and Pre-clinical Trials
  • Exposure to test therapy Drug Products for Stability Studies and other Tests
  • Assessment of test therapy results Devices for non-clinical laboratory studies - in-vivo and in-vitro
  • Reporting of adverse events Tissue Sample for bench science studies

8.23.2 8.25.2 References to this Resource

No resources refer to this resource directly.
    This resource does not implement any patterns.
  • Resource References: AdverseEvent

8.23.3 8.25.3 Resource Content

Structure

Σ
Name Flags Card. Type Description & Constraints doco
. . ResearchSubject TU DomainResource Physical entity Participant or object which is the primary unit recipient of interest investigative activities in the 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
ResearchSubjectStatus Binding: Research Subject State ( Required )
. . . . milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone ( Example )
.. . . period reason 0..1 CodeableConcept State change reason
Binding: State Change Reason ( 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
. . individual . subject Σ 1..1 Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct ) Who or what is part of study
. . assignedArm . assignedComparisonGroup 0..1 string id What path should be followed
. . actualArm . actualComparisonGroup 0..1 string id What path was followed
. . . consent 0..1 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 current publication state of the subject resource (not of the subject) (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) ResearchSubjectStatus 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 or person, animal who is or other entity involved in the study individual 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 assignedArm assignedComparisonGroup : string id [0..1] The name of the arm in the study the subject actually followed as part of this study actualArm actualComparisonGroup : string id [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..1] [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><!-- 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>
 <</individual>
 <
 <
 <</consent>

 <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:;

[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:

  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 since R4

ResearchSubject
ResearchSubject.status
  • No Changes 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-draft-final
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 as XML or JSON .

Conversions between R3 and R4 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

Σ
Name Flags Card. Type Description & Constraints doco
. . ResearchSubject TU DomainResource Physical entity Participant or object which is the primary unit recipient of interest investigative activities in the 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
ResearchSubjectStatus Binding: Research Subject State ( Required )
. . . . milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: Research Subject Milestone ( Example )
. . . . period reason 0..1 CodeableConcept State change reason
Binding: State Change Reason ( 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
. . individual . subject Σ 1..1 Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct ) Who or what is part of study
. . assignedArm . assignedComparisonGroup 0..1 string id What path should be followed
. . actualArm . actualComparisonGroup 0..1 string id What path was followed
. . . consent 0..1 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 current publication state of the subject resource (not of the subject) (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) ResearchSubjectStatus 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 or person, animal who is or other entity involved in the study individual 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 assignedArm assignedComparisonGroup : string id [0..1] The name of the arm in the study the subject actually followed as part of this study actualArm actualComparisonGroup : string id [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..1] [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><!-- 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>
 <</individual>
 <
 <
 <</consent>

 <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:;

[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:

  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 since Release 4

ResearchSubject
ResearchSubject.status
  • No Changes 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-draft-final
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 as XML or JSON .

Conversions between R3 and R4 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 Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis

8.23.3.1 8.25.3.1 Terminology Bindings

Path Definition ValueSet Type Reference Documentation
ResearchSubject.status PublicationStatus Required ResearchSubjectStatus

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 Example

Indicates why the state of the subject changed.

8.23.4 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

8.23.5 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 Resources
identifier token Business Identifier for research subject in a study ResearchSubject.identifier 65 Resources
individual patient reference Who or what is part of study ResearchSubject.individual ResearchSubject.subject.where(resolve() is Patient)
( Patient ) 		66 Resources
patient 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.individual ResearchSubject.subject
( Group , Specimen , BiologicallyDerivedProduct , Device , Medication , Patient , Substance )
status 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.status study reference Study subject is part of ResearchSubject.study ( ResearchStudy ) ResearchSubject.progress.subjectState