FHIR Release 3 (STU) 5 Preview #3
This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 4.0.1 . For a full list of available versions, see the Directory of published versions

8.23 Resource ResearchSubject - Content

Regulated Clinical Biomedical Research Information Management and Regulation Work Group Maturity Level : 0   Draft Trial Use Security Category : Patient Compartments : 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 physical entity which is the gathering primary unit of information about human or animal subjects. 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 subject, including the gender, birthdate, study, study arm, consent status, and promote HL7 standards by developing RCRIM 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 is referenced by adverseevent does not implement any patterns.

Structure

Name Flags Card. Type Description & Constraints doco
. . ResearchSubject TU DomainResource Investigation to increase healthcare-related patient-independent knowledge 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..1 0..* Identifier Business Identifier for research subject in a study
. . . status ?! Σ 1..1 code candidate | enrolled eligible | active follow-up | suspended ineligible | withdrawn not-registered | completed off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectStatus ( Required )
. . . progress 0..* BackboneElement Subject status
.. . . type 0..1 CodeableConcept Kind of state that is being described
ResearchSubjectStateType ( Example )
.... state 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
ResearchSubjectState ( Example )
.... milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
ResearchSubjectMilestone ( Example )
.... reason 0..1 CodeableConcept State change reason
StateChangeReason ( Example )
.... startDate 1..1 dateTime State change date
. . . 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

UML Diagram ( Legend )

ResearchSubject ( DomainResource ) Identifiers assigned to this research subject for a study by the sponsor or other systems identifier : Identifier [0..1] [0..*] The current state of the subject (this element modifies the meaning of other elements) status : code [1..1] « Indicates the progression of a study subject through a study study. (Strength=Required) ResearchSubjectStatus ! » 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 animal who is involved in the study individual : Reference [1..1] « Patient » The name of the arm in the study the subject is expected to follow as part of this study assignedArm : string [0..1] The name of the arm in the study the subject actually followed as part of this study actualArm : string [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..1] « Consent » Progress Identifies the aspect of the subject's journey that the state refers to type : CodeableConcept [0..1] « Identifies the kind of state being refered to. (Strength=Example) ResearchSubjectStateType ?? » The current state of the subject state : CodeableConcept [0..1] « Indicates the progression of a study subject through a study. (Strength=Example) ResearchSubjectState ?? » The milestones the subject has passed through milestone : CodeableConcept [0..1] « Indicates the progression of a study subject through the study milestones. (Strength=Example) ResearchSubjectMilestone ?? » The reason for the state change. If coded it should follow the formal subject state model reason : CodeableConcept [0..1] « Indicates why the state of the subject changed. (Strength=Example) StateChangeReason ?? » The date when the change in status occurred startDate : dateTime [1..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>
 <

 <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 -->
 <progress>  <!-- 0..* Subject status -->
  <type><!-- 0..1 CodeableConcept Kind of state that is being described --></type>
  <state><!-- 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 --></state>
  <milestone><!-- 0..1 CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <reason><!-- 0..1 CodeableConcept State change reason --></reason>
  <startDate value="[dateTime]"/><!-- 1..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><!-- 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>

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: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.progress [ # 0..* Subject status
    fhir:ResearchSubject.progress.type [ CodeableConcept ]; # 0..1 Kind of state that is being described
    fhir:ResearchSubject.progress.state [ 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:ResearchSubject.progress.milestone [ CodeableConcept ]; # 0..1 SignedUp | Screened | Randomized
    fhir:ResearchSubject.progress.reason [ CodeableConcept ]; # 0..1 State change reason
    fhir:ResearchSubject.progress.startDate [ dateTime ]; # 1..1 State change date
  ], ...;

  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 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|4.5.0
ResearchSubject.progress
  • Added Element
ResearchSubject.progress.type
  • Added Element
ResearchSubject.progress.state
  • Added Element
ResearchSubject.progress.milestone
  • Added Element
ResearchSubject.progress.reason
  • Added Element
ResearchSubject.progress.startDate
  • Added Mandatory Element

This resource did not exist in Release 2 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 TU DomainResource Investigation to increase healthcare-related patient-independent knowledge 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..1 0..* Identifier Business Identifier for research subject in a study
. . . status ?! Σ 1..1 code candidate | enrolled eligible | active follow-up | suspended ineligible | withdrawn not-registered | completed off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectStatus ( Required )
. . . progress 0..* BackboneElement Subject status
.... type 0..1 CodeableConcept Kind of state that is being described
ResearchSubjectStateType ( Example )
.... state 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
ResearchSubjectState ( Example )
. . . . milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
ResearchSubjectMilestone ( Example )
.... reason 0..1 CodeableConcept State change reason
StateChangeReason ( Example )
.... startDate 1..1 dateTime State change date
. . . 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

UML Diagram ( Legend )

ResearchSubject ( DomainResource ) Identifiers assigned to this research subject for a study by the sponsor or other systems identifier : Identifier [0..1] [0..*] The current state of the subject (this element modifies the meaning of other elements) status : code [1..1] « Indicates the progression of a study subject through a study study. (Strength=Required) ResearchSubjectStatus ! » 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 animal who is involved in the study individual : Reference [1..1] « Patient » The name of the arm in the study the subject is expected to follow as part of this study assignedArm : string [0..1] The name of the arm in the study the subject actually followed as part of this study actualArm : string [0..1] A record of the patient's informed agreement to participate in the study consent : Reference [0..1] « Consent » Progress Identifies the aspect of the subject's journey that the state refers to type : CodeableConcept [0..1] « Identifies the kind of state being refered to. (Strength=Example) ResearchSubjectStateType ?? » The current state of the subject state : CodeableConcept [0..1] « Indicates the progression of a study subject through a study. (Strength=Example) ResearchSubjectState ?? » The milestones the subject has passed through milestone : CodeableConcept [0..1] « Indicates the progression of a study subject through the study milestones. (Strength=Example) ResearchSubjectMilestone ?? » The reason for the state change. If coded it should follow the formal subject state model reason : CodeableConcept [0..1] « Indicates why the state of the subject changed. (Strength=Example) StateChangeReason ?? » The date when the change in status occurred startDate : dateTime [1..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>
 <

 <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 -->
 <progress>  <!-- 0..* Subject status -->
  <type><!-- 0..1 CodeableConcept Kind of state that is being described --></type>
  <state><!-- 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 --></state>
  <milestone><!-- 0..1 CodeableConcept SignedUp | Screened | Randomized --></milestone>
  <reason><!-- 0..1 CodeableConcept State change reason --></reason>
  <startDate value="[dateTime]"/><!-- 1..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><!-- 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>

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: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.progress [ # 0..* Subject status
    fhir:ResearchSubject.progress.type [ CodeableConcept ]; # 0..1 Kind of state that is being described
    fhir:ResearchSubject.progress.state [ 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:ResearchSubject.progress.milestone [ CodeableConcept ]; # 0..1 SignedUp | Screened | Randomized
    fhir:ResearchSubject.progress.reason [ CodeableConcept ]; # 0..1 State change reason
    fhir:ResearchSubject.progress.startDate [ dateTime ]; # 1..1 State change date
  ], ...;

  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.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|4.5.0
ResearchSubject.progress
  • Added Element
ResearchSubject.progress.type
  • Added Element
ResearchSubject.progress.state
  • Added Element
ResearchSubject.progress.milestone
  • Added Element
ResearchSubject.progress.reason
  • Added Element
ResearchSubject.progress.startDate
  • Added Mandatory Element

This resource did not exist in Release 2 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 (for ) + 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
ResearchSubject.progress.type Identifies the kind of state being refered to. Example ResearchSubjectStateType
ResearchSubject.progress.state Indicates the progression of a study subject through a study. Example ResearchSubjectState
ResearchSubject.progress.milestone Indicates the progression of a study subject through the study milestones. Example ResearchSubjectMilestone
ResearchSubject.progress.reason Indicates why the state of the subject changed. Example StateChangeReason

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 )
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.progress.state
status N token candidate | enrolled eligible | active follow-up | suspended ineligible | withdrawn not-registered | completed 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 )