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8.29 Ресурс ResearchSubject - Назначение

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.

This resource supports the HL7 mission to create and promote HL7 standards by developing Biomedical Research and Regulation 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.

Структура

ИмяФлагиКард.ТипОписание и ограниченияdoco
.. ResearchSubject TUDomainResourcePhysical entity which is the primary unit of interest in the study
Элементы, определённые в прародителе: 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn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 Документация по этому формату

Turtle-шаблон

@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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn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
  • Remove Codes enrolled, active, suspended, completed
  • Add Codes eligible, follow-up, ineligible, not-registered, off-study, on-study, on-study-intervention, on-study-observation, pending-on-study, potential-candidate, screening

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.)

Структура

ИмяФлагиКард.ТипОписание и ограниченияdoco
.. ResearchSubject TUDomainResourcePhysical entity which is the primary unit of interest in the study
Элементы, определённые в прародителе: 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 Документация по этому формату

Turtle-шаблон

@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
  • Remove Codes enrolled, active, suspended, completed
  • Add Codes eligible, follow-up, ineligible, not-registered, off-study, on-study, on-study-intervention, on-study-observation, pending-on-study, potential-candidate, screening

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 Альтернативные определения: Основное определение XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the Анализ зависимостей

PathОписаниеТипСсылка
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

Параметры поиска для этого ресурса. Также к нему применяются общие параметры. Более подробную информацию о поиске в REST, обмене сообщениями и сервисах см. в разделе Поиск.

ИмяТипОпределениеВыражениеIn 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)