HL7 Terminology (THO)
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This page is part of the HL7 Terminology (v5.3.0: Release) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

CodeSystem: ResearchSubjectState

Official URL: http://terminology.hl7.org/CodeSystem/research-subject-state Version: 0.1.0
Draft as of 2020-04-09 Maturity Level: 1 Responsible: HL7 (FHIR Project) Computable Name: ResearchSubjectState
Other Identifiers: id: urn:oid:2.16.840.1.113883.4.642.1.0

Indicates the progression of a study subject through a study.

This Code system is referenced in the content logical definition of the following value sets:

This case-sensitive code system http://terminology.hl7.org/CodeSystem/research-subject-state defines the following codes:

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.


2020-10-14reviseVocabulary WGGrahame GrieveReset Version after migration to UTG
2020-05-06reviseVocabulary WGTed KleinMigrated to the UTG maintenance environment and publishing tooling.