HL7 Terminology (THO)
5.4.0 - Publication
HL7 Terminology (THO)
5.4.0 - Publication
This page is part of the HL7 Terminology (v5.4.0: Release) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Draft as of 2020-04-09 | Maturity Level: 1 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-subject-state"/>
<meta>
<lastUpdated value="2020-04-09T21:10:28.568+00:00"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/research-subject-state</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">candidate<a name="research-subject-state-candidate"> </a></td><td>Candidate</td><td><div><p>An identified person that can be considered for inclusion in a study.</p>
</div></td></tr><tr><td style="white-space:nowrap">eligible<a name="research-subject-state-eligible"> </a></td><td>Eligible</td><td><div><p>A person that has met the eligibility criteria for inclusion in a study.</p>
</div></td></tr><tr><td style="white-space:nowrap">follow-up<a name="research-subject-state-follow-up"> </a></td><td>Follow-up</td><td><div><p>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.</p>
</div></td></tr><tr><td style="white-space:nowrap">ineligible<a name="research-subject-state-ineligible"> </a></td><td>Ineligible</td><td><div><p>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.</p>
</div></td></tr><tr><td style="white-space:nowrap">not-registered<a name="research-subject-state-not-registered"> </a></td><td>Not Registered</td><td><div><p>A person for whom registration was not completed.</p>
</div></td></tr><tr><td style="white-space:nowrap">off-study<a name="research-subject-state-off-study"> </a></td><td>Off-study</td><td><div><p>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.</p>
</div></td></tr><tr><td style="white-space:nowrap">on-study<a name="research-subject-state-on-study"> </a></td><td>On-study</td><td><div><p>A person that is enrolled or registered on a study.</p>
</div></td></tr><tr><td style="white-space:nowrap">on-study-intervention<a name="research-subject-state-on-study-intervention"> </a></td><td>On-study-intervention</td><td><div><p>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</p>
</div></td></tr><tr><td style="white-space:nowrap">on-study-observation<a name="research-subject-state-on-study-observation"> </a></td><td>On-study-observation</td><td><div><p>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".</p>
</div></td></tr><tr><td style="white-space:nowrap">pending-on-study<a name="research-subject-state-pending-on-study"> </a></td><td>Pending on-study</td><td><div><p>A person is pre-registered for a study.</p>
</div></td></tr><tr><td style="white-space:nowrap">potential-candidate<a name="research-subject-state-potential-candidate"> </a></td><td>Potential Candidate</td><td><div><p>A person that is potentially eligible for participation in the study.</p>
</div></td></tr><tr><td style="white-space:nowrap">screening<a name="research-subject-state-screening"> </a></td><td>Screening</td><td><div><p>A person who is being evaluated for eligibility for a study.</p>
</div></td></tr><tr><td style="white-space:nowrap">withdrawn<a name="research-subject-state-withdrawn"> </a></td><td>Withdrawn</td><td><div><p>The person has withdrawn their participation in the study before registration.</p>
</div></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
</extension>
<url value="http://terminology.hl7.org/CodeSystem/research-subject-state"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.1.0"/>
</identifier>
<version value="1.0.0"/>
<name value="ResearchSubjectState"/>
<title value="ResearchSubjectState"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2020-04-09T21:10:28+00:00"/>
<publisher value="Health Level Seven International"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://hl7.org"/>
</telecom>
<telecom>
<system value="email"/>
<value value="hq@HL7.org"/>
</telecom>
</contact>
<description
value="Indicates the progression of a study subject through a study."/>
<copyright
value="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"/>
<caseSensitive value="true"/>
<valueSet
value="http://terminology.hl7.org/ValueSet/research-subject-state"/>
<content value="complete"/>
<concept>
<code value="candidate"/>
<display value="Candidate"/>
<definition
value="An identified person that can be considered for inclusion in a study."/>
</concept>
<concept>
<code value="eligible"/>
<display value="Eligible"/>
<definition
value="A person that has met the eligibility criteria for inclusion in a study."/>
</concept>
<concept>
<code value="follow-up"/>
<display value="Follow-up"/>
<definition
value="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."/>
</concept>
<concept>
<code value="ineligible"/>
<display value="Ineligible"/>
<definition
value="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."/>
</concept>
<concept>
<code value="not-registered"/>
<display value="Not Registered"/>
<definition value="A person for whom registration was not completed."/>
</concept>
<concept>
<code value="off-study"/>
<display value="Off-study"/>
<definition
value="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."/>
</concept>
<concept>
<code value="on-study"/>
<display value="On-study"/>
<definition value="A person that is enrolled or registered on a study."/>
</concept>
<concept>
<code value="on-study-intervention"/>
<display value="On-study-intervention"/>
<definition
value="The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating."/>
</concept>
<concept>
<code value="on-study-observation"/>
<display value="On-study-observation"/>
<definition
value="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"."/>
</concept>
<concept>
<code value="pending-on-study"/>
<display value="Pending on-study"/>
<definition value="A person is pre-registered for a study."/>
</concept>
<concept>
<code value="potential-candidate"/>
<display value="Potential Candidate"/>
<definition
value="A person that is potentially eligible for participation in the study."/>
</concept>
<concept>
<code value="screening"/>
<display value="Screening"/>
<definition
value="A person who is being evaluated for eligibility for a study."/>
</concept>
<concept>
<code value="withdrawn"/>
<display value="Withdrawn"/>
<definition
value="The person has withdrawn their participation in the study before registration."/>
</concept>
</CodeSystem>
IG © 2020+ HL7 International - Vocabulary Work Group. Package hl7.terminology#5.4.0 based on FHIR 4.0.1. Generated 2023-11-17
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