FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 3). 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

Regulated Clinical Research Information Management Work GroupMaturity Level: 0 DraftCompartments: Patient

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

This resource supports the HL7 mission to create and promote HL7 standards by developing RCRIM standards to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

This resource is referenced by adverseevent

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject DomainResourceInvestigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness Identifier for research subject
... status ?!Σ1..1codecandidate | enrolled | active | suspended | withdrawn | completed
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

XML Template

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..1 Business Identifier for research subject
  fhir:ResearchSubject.status [ code ]; # 1..1 candidate | enrolled | active | suspended | withdrawn | completed
  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 DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchSubject DomainResourceInvestigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness Identifier for research subject
... status ?!Σ1..1codecandidate | enrolled | active | suspended | withdrawn | completed
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

XML Template

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..1 Business Identifier for research subject
  fhir:ResearchSubject.status [ code ]; # 1..1 candidate | enrolled | active | suspended | withdrawn | completed
  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 DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

Alternate definitions: Master Definition (XML, JSON), XML Schema/Schematron (for ) + JSON Schema, ShEx (for Turtle)

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

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 subjectResearchSubject.identifier
individualreferenceWho is part of studyResearchSubject.individual
(Patient)
patientreferenceWho is part of studyResearchSubject.individual
(Patient)
statustokencandidate | enrolled | active | suspended | withdrawn | completedResearchSubject.status