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\nis 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\nresponding, 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withdrawn | Withdrawn | The person has withdrawn their participation in the study before registration. |