R4 Ballot #1 (Mixed Normative/Trial use) Current Build
This page was published as part of FHIR v3.3.0: R4 Ballot #1 : Mixed Normative/Trial use (First Normative ballot). It has been superceded by R4 . For a full list of available versions, see the Directory of published versions .

8.26 8.23 Resource ResearchSubject - Content

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

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

This 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 supports describes essential information about the HL7 mission to create and promote HL7 standards by developing Biomedical Research subject, including the gender, birthdate, study, study arm, consent status, and Regulation standards other key items. Human research subjects are usually not traceable to improve or enhance information management during clinical a particular person to protect the subject’s privacy.

The ResearchSubject resource is used in the following research activities:

  • Consent and regulatory evaluation registration to a research study
  • Exposure to test therapy
  • Assessment of the safety, efficacy and quality test therapy results
  • Reporting of therapeutic products and procedures worldwide. adverse events

No resources refer to this resource directly.

This resource does not implement any patterns.

Structure

Name Flags Card. Type Description & Constraints doco
. . ResearchSubject D TU DomainResource Physical entity which is the primary unit of interest in the 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 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn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 ( Required )
. . . period Σ 0..1 Period Start and end of participation
. . . study Σ 1..1 Reference ( ResearchStudy ) Study subject is part of
. . . individual Σ 1..1 Reference ( Patient ) Who is part of study
. . . assignedArm 0..1 string What path should be followed
. . . actualArm 0..1 string What path was followed
. . . consent 0..1 Reference ( 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 ResearchSubject.status
  • Max Cardinality changed Change value set from 1 http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to * http://hl7.org/fhir/ValueSet/research-subject-status|4.1.0

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

Name Flags Card. Type Description & Constraints doco
. . ResearchSubject D TU DomainResource Physical entity which is the primary unit of interest in the 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 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 ( Required )
. . . period Σ 0..1 Period Start and end of participation
. . . study Σ 1..1 Reference ( ResearchStudy ) Study subject is part of
. . . individual Σ 1..1 Reference ( Patient ) Who is part of study
. . . assignedArm 0..1 string What path should be followed
. . . actualArm 0..1 string What path was followed
. . . consent 0..1 Reference ( 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 DSTU2 Release 3

ResearchSubject
ResearchSubject.identifier ResearchSubject.status
  • Max Cardinality changed Change value set from 1 http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0 to * http://hl7.org/fhir/ValueSet/research-subject-status|4.1.0

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.)

 

Alternate See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis a

Path Definition Type Reference
ResearchSubject.status Indicates the progression of a study subject through a study study. Required ResearchSubjectStatus

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.

Name Type Description Expression In Common
date date Start and end of participation ResearchSubject.period
identifier token Business Identifier for research subject in a study ResearchSubject.identifier
individual reference Who is part of study ResearchSubject.individual
( Patient )
patient reference Who is part of study ResearchSubject.individual
( Patient )
status 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 )