ResearchSubjectState

ResearchSubjectState

draftExtensions for Using Data Elements from FHIR R5 in FHIR R40.1.0complete13 concepts

Indicates the progression of a study subject through a study.

Metadata

hl7.org/fhir
Canonical URL
http://terminology.hl7.org/CodeSystem/research-subject-state
ID
research-subject-state
Version
0.1.0
Publisher
Biomedical Research and Regulation
Case Sensitive
Yes

Concepts (13)

CodeDisplayDefinition
candidateCandidateAn identified person that can be considered for inclusion in a study.
eligibleEligibleA person that has met the eligibility criteria for inclusion in a study.
follow-upFollow-upA person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule.
ineligibleIneligibleA person who did not meet one or more criteria required for participation in a study is considered to have failed screening or is ineligible for the study.
not-registeredNot RegisteredA person for whom registration was not completed.
off-studyOff-studyA person that has ended their participation on a study either because their treatment/observation is complete or through not responding, withdrawal, non-compliance and/or adverse event.
on-studyOn-studyA person that is enrolled or registered on a study.
on-study-interventionOn-study-interventionThe person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.
on-study-observationOn-study-observationThe subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is "short-term follow-up".
pending-on-studyPending on-studyA person is pre-registered for a study.
potential-candidatePotential CandidateA person that is potentially eligible for participation in the study.
screeningScreeningA person who is being evaluated for eligibility for a study.
withdrawnWithdrawnThe person has withdrawn their participation in the study before registration.