FHIR Release 3 (STU) R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.0.2: STU 3). (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R4B R4 R3

4.3.1.804 4.4.1.501 Value Set http://hl7.org/fhir/ValueSet/research-subject-status

Regulated Clinical Biomedical Research Information Management and Regulation Work Group   Maturity Level : 0 Informative Trial Use Use Context : Any

This is a value set defined by the FHIR project.

Summary

Defining URL: http://hl7.org/fhir/ValueSet/research-subject-status
Version: 3.5.0
Name: ResearchSubjectStatus
Title: ResearchSubjectStatus
Definition:

Indicates the progression of a study subject through a study study.

Committee: Regulated Clinical Biomedical Research Information Management and Regulation Work Group
OID: 2.16.840.1.113883.4.642.3.804 2.16.840.1.113883.4.642.3.829 (for OID based terminology systems)
Source Resource XML / JSON

This value set is used in the following places:

4.3.1.804.1 4.4.1.501.1 Content Logical Definition

This value set includes codes from the following code systems:

 

4.3.1.804.2 4.4.1.501.2 Expansion

This expansion generated 19 Apr 2017 Aug 2018

This value set contains 6 13 concepts

Expansion based on http://hl7.org/fhir/research-subject-status version 3.0.2 3.5.0

All codes from system http://hl7.org/fhir/research-subject-status

Code Display Definition Canonical Status
candidate Candidate The subject has been An identified as a potential participant 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 has they are being monitored on a protocol-prescribed schedule. ~ replaced
ineligible Ineligible A person who did not yet agreed meet one or more criteria required for participation in a study is considered to participate have failed screening or is ineligible for the study. ~ declined
not-registered Not Registered A person for whom registration was not completed. ~ abandoned enrolled
off-study Enrolled Off-study The subject A person that has agreed to participate in the ended their participation on a study but has either because their treatment/observation is complete or through not yet begun performing any action within the study responding, withdrawal, non-compliance and/or adverse event. ~ complete
on-study On-study A person that is enrolled or registered on a study.
active on-study-intervention Active On-study-intervention The subject person is currently being monitored and/or subject to receiving the treatment as part of or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.
suspended on-study-observation Suspended On-study-observation The subject has temporarily discontinued monitoring/treatment as part of 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. ~ suspended withdrawn
potential-candidate Withdrawn Potential Candidate The subject has permanently ended A person that is potentially eligible for participation in the study prior to completion of the intended monitoring/treatment study.
screening Screening A person who is being evaluated for eligibility for a study.
completed withdrawn Completed Withdrawn All intended monitoring/treatment of the subject The person has been completed and withdrawn their engagement with participation in the study is now ended before registration. ~ failed

 

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Level Lvl A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes For value sets, levels are under other codes, and imply that the mostly used to organize codes for user convenience, but may follow code they are under also applies system hierarchy - see Code System for further information
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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
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