HL7 Terminology
2.0.0 - Publication

This page is part of the HL7 Terminology (v2.0.0: Release) based on FHIR R4. The current version which supercedes this version is 5.2.0. For a full list of available versions, see the Directory of published versions

CodeSystem: ResearchSubjectState


Defining URL:http://terminology.hl7.org/CodeSystem/research-subject-state
Status:Draft as of 2020-04-09T21:10:28+00:00 (Standards Status: Draft)

Indicates the progression of a study subject through a study.

Publisher:HL7 (FHIR Project)
Committee:Biomedical Research and Regulation
Content:Complete: All the concepts defined by the code system are included in the code system resource
OID:2.16.840.1.113883.4.642.1.0 (for OID based terminology systems)
Value Set:http://terminology.hl7.org/ValueSet/research-subject-state ( is the value set for all codes in this code system)
Source Resource:XML / JSON / Turtle

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

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

candidate CandidateAn identified person that can be considered for inclusion in a study.
eligible EligibleA person that has met the eligibility criteria for inclusion in a study.
follow-up Follow-upA 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 IneligibleA 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 RegisteredA person for whom registration was not completed.
off-study Off-studyA 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-studyA person that is enrolled or registered on a study.
on-study-intervention On-study-interventionThe 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-observationThe 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-studyA person is pre-registered for a study.
potential-candidate Potential CandidateA person that is potentially eligible for participation in the study.
screening ScreeningA person who is being evaluated for eligibility for a study.
withdrawn WithdrawnThe person has withdrawn their participation in the study before registration.


2020-10-14reviseGrahame GrieveVocabulary WGReset Version after migration to UTG
2020-05-06reviseTed KleinVocabulary WGMigrated to the UTG maintenance environment and publishing tooling.