4.3.14.407 Code System http://hl7.org/fhir/research-subject-status

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Use Context: Any

This is a code system defined by the FHIR project.

Summary

Defining URL:

http://hl7.org/fhir/research-subject-status

Version:

4.1.0

Name:

ResearchSubjectStatus

Title:

ResearchSubjectStatus

Definition:

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 (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.)

4.3.14.407.1 Content

4.3.14.407.2 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.

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