This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions
Biomedical Research and Regulation ![]() | Maturity Level: 0 | Trial Use | Security Category: Patient | Compartments: Device, Patient |
A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.
A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above.
The ResearchSubject resource describes information about the subject in the context of a research study.
Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject's privacy.
Note that in a human drug trial the human is the research subject even though the drug is what is being investigated.
The scope of ResearchSubject is intended to support the following use cases:
The Subject State is the research subject's (participant’s) movement through the study protocol from the subject's point of view. The Subject Milestone is how the study activities relate to the subject's movement through the study protocol. The two are separate. State is driven by the subject and the Milestone is driven by the study protocol. The values in each element may be the same if necessary for study reasons.
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
Path | ValueSet | Type | Documentation |
---|---|---|---|
ResearchSubject.status | PublicationStatus | Required | The lifecycle status of an artifact. |
ResearchSubject.subjectState.code | ResearchSubjectState | Extensible | Indicates the progression of a study subject through a study. |
ResearchSubject.subjectState.reason | StateChangeReason ![]() |
Example | Indicates why the state of the subject changed. |
ResearchSubject.subjectMilestone.milestone | ResearchSubjectMilestone | Extensible | Indicates the progression of a study subject through the study milestones. |
The following diagram reflects the "typical" state machine for ResearchSubject.
Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to 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 | 26 Resources |
identifier | token | Business Identifier for research subject in a study | ResearchSubject.identifier | 65 Resources |
patient | reference | Who or what is part of study | ResearchSubject.subject.where(resolve() is Patient) (Patient) |
65 Resources |
status | token | draft | active | retired | unknown | ResearchSubject.status | |
study | reference | Study subject is part of | ResearchSubject.study (ResearchStudy) |
|
subject | reference | Who or what is part of study | ResearchSubject.subject (Group, Specimen, BiologicallyDerivedProduct, Device, Medication, Patient, Substance) |
|
subject_state | token | candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study | ResearchSubject.subjectState.code |