HL7 Terminology (THO)
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HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 7.4.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

CodeSystem: ResearchSubjectState

Official URL: http://terminology.hl7.org/CodeSystem/research-subject-state Version: 2.0.0
Active as of 2024-04-24 Maturity Level: 1 Responsible: Health Level Seven International Computable Name: ResearchSubjectState
Other Identifiers: OID:2.16.840.1.113883.4.642.1.0

Copyright/Legal: This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license

Indicates the progression of a study subject through a study.

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

Last updated: 2024-04-24 00:00:00+0000

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

CodeDisplayDefinition
candidate Candidate

A subject (ResearchSubject) potentially eligible for participation in a study (ResearchStudy) who has not completed an evaluation to determine whether they are eligible or ineligible for consideration.

in-prescreening In-Prescreening

A subject (ResearchSubject) potentially eligible for participation in a study (ResearchStudy) who has not completed an evaluation to determine whether they are eligible or ineligible for consideration.

in-screening In-Screening

A subject (ResearchSubject) undergoing a full evaluation to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy).

eligible Eligible

A subject (ResearchSubject) who has passed a full evaluation against the protocol specified eligibility criteria to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy).

ineligible Ineligible

A subject (ResearchSubject) who has failed an evaluation against the protocol specified eligibility criteria to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy).

on-study On-Study

A subject (ResearchSubject) who is enrolled in a study (ResearchStudy). In a retrospective study context: the start of the period during which a subject's data is included, observed, or considered as part of the study analysis.

on-study-intervention On-Study-Intervention

A subject (ResearchSubject) who is in an intervention phase of a study (ResearchStudy).

in-follow-up In-Follow-Up

A subject (ResearchSubject) who has completed planned study (ResearchStudy) procedures and tests and is being monitored based on a protocol-prescribed schedule.

off-study Off-Study

A subject (ResearchSubject) who is no longer participating in a study (ResearchStudy). In a retrospective study context: the end of the period during which a subject's data is included, observed, or considered as part of the study analysis.

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.

not-registered Not Registered

A person for whom registration was not completed.

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.


Description of the above table(s).


History

DateActionAuthorCustodianComment
2026-09-18reviseKhalid ShahinBRRChange the ResearchSubjectState CodeSystem terms for ResearchSubject; up-585
2023-11-14reviseMarc DuteauTSMGAdd standard copyright and contact to internal content; up-476
2020-10-14reviseGrahame GrieveVocabulary WGReset Version after migration to UTG
2020-05-06reviseTed KleinVocabulary WGMigrated to the UTG maintenance environment and publishing tooling.