<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-subject-state"/>
  <meta>
    <lastUpdated value="2024-04-24T00:00:00+00:00"/>
  </meta>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem research-subject-state</b></p><a name="research-subject-state"> </a><a name="hcresearch-subject-state"> </a><a name="research-subject-state-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Last updated: 2024-04-24 00:00:00+0000</p></div><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 &quot;short-term follow-up&quot;.</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="1.0.1"/>
  <name value="ResearchSubjectState"/>
  <title value="ResearchSubjectState"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-04-24T00:00:00+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&#xA;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&#xA;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 &quot;short-term follow-up&quot;."/>
  </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>