Release 4
This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU ). This is the current published version in it's permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions Code System

Biomedical Research and Regulation Work Group   Maturity Level : 1 0 Trial Use Use Context : Any

This is a code system defined by the FHIR project.


Defining URL:
Version: 4.0.1 4.2.0
Name: ResearchSubjectStatus
Title: ResearchSubjectStatus

Indicates the progression of a study subject through a study.

Committee: Biomedical Research and Regulation Work Group
OID: 2.16.840.1.113883.4.642.4.830 2.16.840.1.113883.4.642.1.830 (for OID based terminology systems)
Source Resource XML / JSON

This Code system is used in the following value sets:

  • ValueSet: ResearchSubjectStatus (Indicates the progression of a study subject through a study.)
  • ValueSet: ResearchSubjectStatus (Indicates the progression of a study subject through a study.)

Indicates the progression of a study subject through a study.

This code system 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.


See the full registry of code systems defined as part of FHIR.

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. See Code System for further information.
Source The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
Display The display (used in the display element of a Coding ). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code