Resource type: researchsubject

Description

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

Elements

PathShortDefinitionComments
Physical entity which is the primary unit of interest in the studyA physical entity which is the primary unit of operational and/or administrative interest in a study.Need to make sure we encompass public health studies.
identifierBusiness Identifier for research subject in a studyIdentifiers assigned to this research subject for a study.
statuscandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawnThe current state of the subject.
periodStart and end of participationThe dates the subject began and ended their participation in the study.
studyStudy subject is part ofReference to the study the subject is participating in.
individualWho is part of studyThe record of the person or animal who is involved in the study.
assignedArmWhat path should be followedThe name of the arm in the study the subject is expected to follow as part of this study.
actualArmWhat path was followedThe name of the arm in the study the subject actually followed as part of this study.
consentAgreement to participate in studyA record of the patient's informed agreement to participate in the study.


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:



ResearchSubject State Machine

The following diagram reflects the "typical" state machine for ResearchSubject.

Diagram showing typical state machine for the ResearchSubject resource

Search Parameters

dateStart and end of participationResearchSubject.period
identifierBusiness Identifier for research subject in a studyResearchSubject.identifier
individualWho is part of studyResearchSubject.individual
patientWho is part of studyResearchSubject.individual
statuscandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawnResearchSubject.status
studyStudy subject is part ofResearchSubject.study

Extension Definitions

These are extension definitions for this resource defined by the spec