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8.23 Resource ResearchSubject - Content

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

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

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

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..1codecandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectStatus (Required)
... period Σ0..1PeriodStart and end of participation
... study Σ1..1Reference(ResearchStudy)Study subject is part of
... individual Σ1..1Reference(Patient)Who 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

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 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.period [ Period ]; # 0..1 Start and end of participation
  fhir:ResearchSubject.study [ Reference(ResearchStudy) ]; # 1..1 Study subject is part of
  fhir:ResearchSubject.individual [ Reference(Patient) ]; # 1..1 Who 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.identifier
  • Max Cardinality changed from 1 to *
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0

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..1codecandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectStatus (Required)
... period Σ0..1PeriodStart and end of participation
... study Σ1..1Reference(ResearchStudy)Study subject is part of
... individual Σ1..1Reference(Patient)Who 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

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 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.period [ Period ]; # 0..1 Start and end of participation
  fhir:ResearchSubject.study [ Reference(ResearchStudy) ]; # 1..1 Study subject is part of
  fhir:ResearchSubject.individual [ Reference(Patient) ]; # 1..1 Who 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.identifier
  • Max Cardinality changed from 1 to *
ResearchSubject.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-subject-status to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0

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 dependency analysis

PathDefinitionTypeReference
ResearchSubject.status Indicates the progression of a study subject through a study.RequiredResearchSubjectStatus

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
individualreferenceWho is part of studyResearchSubject.individual
(Patient)
patientreferenceWho is part of studyResearchSubject.individual
(Patient)
statustokencandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawnResearchSubject.status
studyreferenceStudy subject is part ofResearchSubject.study
(ResearchStudy)