ResearchSubjectStatus

ResearchSubjectStatus

draftcomplete13 conceptsv4.0.1

Indicates the progression of a study subject through a study.

Metadata

hl7.org/fhir
Canonical URL
http://hl7.org/fhir/research-subject-status
All-Codes Value Set
http://hl7.org/fhir/ValueSet/research-subject-status
ID
research-subject-status
Version
4.0.1
Publisher
HL7 (FHIR Project)
Case Sensitive
Yes
In the unified registry

Concepts (13)

candidate
Candidate
An identified person that can be considered for inclusion in a study.
eligible
Eligible
A person that has met the eligibility criteria for inclusion in a study.
follow-up
Follow-up
A 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.
ineligible
Ineligible
A 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-registered
Not Registered
A person for whom registration was not completed.
off-study
Off-study
A 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-study
On-study
A person that is enrolled or registered on a study.
on-study-intervention
On-study-intervention
The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.
on-study-observation
On-study-observation
The 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-study
Pending on-study
A person is pre-registered for a study.
potential-candidate
Potential Candidate
A person that is potentially eligible for participation in the study.
screening
Screening
A person who is being evaluated for eligibility for a study.
withdrawn
Withdrawn
The person has withdrawn their participation in the study before registration.