ResearchSubjectStatus

Indicates the progression of a study subject through a study.

This code system http://hl7.org/fhir/research-subject-status 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withdrawn Withdrawn The person has withdrawn their participation in the study before registration.
<status value="draft"/> <experimental value="false"/> <date value="2018-08-19T21:48:56+10:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="Indicates the progression of a study subject through a study."/> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/research-subject-status"/> <content value="complete"/> <concept> <code value="candidate"/> <display value="Candidate"/> <definition value="An identified person that can be considered for inclusion in a study."/> </concept> <concept> <code value="eligible"/> <display value="Eligible"/> <definition value="A person that has met the eligibility criteria for inclusion in a study."/> </concept> <concept> <code value="follow-up"/> <display value="Follow-up"/> <definition value="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."/> </concept> <concept> <code value="ineligible"/> <display value="Ineligible"/> <definition value="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."/> </concept> <concept> <code value="not-registered"/> <display value="Not Registered"/> <definition value="A person for whom registration was not completed."/> </concept> <concept> <code value="off-study"/> <display value="Off-study"/> <definition value="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."/> </concept> <concept> <code value="on-study"/> <display value="On-study"/> <definition value="A person that is enrolled or registered on a study."/> </concept> <concept> <code value="on-study-intervention"/> <display value="On-study-intervention"/> <definition value="The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating."/> </concept> <concept> <code value="on-study-observation"/> <display value="On-study-observation"/> <definition value="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"."/> </concept> <concept> <code value="pending-on-study"/> <display value="Pending on-study"/> <definition value="A person is pre-registered for a study."/> </concept> <concept> <code value="potential-candidate"/> <display value="Potential Candidate"/> <definition value="A person that is potentially eligible for participation in the study."/> </concept> <concept> <code value="screening"/> <display value="Screening"/> <definition value="A person who is being evaluated for eligibility for a study."/> </concept> <concept> <code value="withdrawn"/> <display value="Withdrawn"/> <definition value="The person has withdrawn their participation in the study before registration."/> </concept> </CodeSystem>