Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Patient

Compartments: Patient

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

8.23.1 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 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

8.23.2 References

No resources refer to this resource directly.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject	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\| on-study \| on-study-intervention \| on-study-observation \| pending-on-study \| potential-candidate \| screening \| withdrawn ResearchSubjectStatus (Required)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
Documentation for this format

UML Diagram (Legend)

XML Template

<ResearchSubject xmlns="http://hl7.org/fhir"> 
 <!-- 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 candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn -->
 <period><!-- 0..1 Period Start and end of participation --></period>
 <study><!-- 1..1 Reference(ResearchStudy) Study subject is part of --></study>
 <individual><!-- 1..1 Reference(Patient) Who is part of study --></individual>
 <assignedArm value="[string]"/><!-- 0..1 What path should be followed -->
 <actualArm value="[string]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..1 Reference(Consent) Agreement to participate in study --></consent>
</ResearchSubject>

JSON Template

{
  "resourceType" : "ResearchSubject",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for research subject in a study
  "status" : "<code>", // R!  candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
  "period" : { Period }, // Start and end of participation
  "study" : { Reference(ResearchStudy) }, // R!  Study subject is part of
  "individual" : { Reference(Patient) }, // R!  Who is part of study
  "assignedArm" : "<string>", // What path should be followed
  "actualArm" : "<string>", // What path was followed
  "consent" : { Reference(Consent) } // Agreement to participate in study
}

Turtle Template

@prefix fhir: <http://hl7.org/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: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.status

Change value set from 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
ResearchSubject	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
Documentation for this format

UML Diagram (Legend)

XML Template

<ResearchSubject xmlns="http://hl7.org/fhir"> 
 <!-- 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 candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn -->
 <period><!-- 0..1 Period Start and end of participation --></period>
 <study><!-- 1..1 Reference(ResearchStudy) Study subject is part of --></study>
 <individual><!-- 1..1 Reference(Patient) Who is part of study --></individual>
 <assignedArm value="[string]"/><!-- 0..1 What path should be followed -->
 <actualArm value="[string]"/><!-- 0..1 What path was followed -->
 <consent><!-- 0..1 Reference(Consent) Agreement to participate in study --></consent>
</ResearchSubject>

JSON Template

{
  "resourceType" : "ResearchSubject",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for research subject in a study
  "status" : "<code>", // R!  candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
  "period" : { Period }, // Start and end of participation
  "study" : { Reference(ResearchStudy) }, // R!  Study subject is part of
  "individual" : { Reference(Patient) }, // R!  Who is part of study
  "assignedArm" : "<string>", // What path should be followed
  "actualArm" : "<string>", // What path was followed
  "consent" : { Reference(Consent) } // Agreement to participate in study
}

Turtle Template

@prefix fhir: <http://hl7.org/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: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.status

Change value set from 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.)

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

8.23.3.1 Terminology Bindings

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

Path

Definition

Type

Reference

ResearchSubject.status

Indicates the progression of a study subject through a study.

Required

ResearchSubjectStatus

8.23.4 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 Search Parameters

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)