This code system http://terminology.hl7.org/CodeSystem/research-subject-state defines the following codes:
Code
|
Display
|
Definition
|
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withdrawn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Withdrawn |
The person has withdrawn their participation in the study before registration. |