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

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="R4B-research-subject-status-for-R5"/>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet R4B-research-subject-status-for-R5</b></p><a name="R4B-research-subject-status-for-R5"> </a><a name="hcR4B-research-subject-status-for-R5"> </a><p>This value set expansion contains 12 concepts.</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>System</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-candidate"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-candidate">candidate</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-eligible"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-eligible">eligible</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-follow-up"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-follow-up">follow-up</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-ineligible"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-ineligible">ineligible</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-not-registered"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-not-registered">not-registered</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-off-study"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-off-study">off-study</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-on-study"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study">on-study</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-on-study-intervention"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study-intervention">on-study-intervention</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-on-study-observation"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study-observation">on-study-observation</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-pending-on-study"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-pending-on-study">pending-on-study</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-potential-candidate"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-potential-candidate">potential-candidate</a></td><td>http://hl7.org/fhir/research-subject-status</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"><a name="R4B-research-subject-status-for-R5-http://hl7.org/fhir/research-subject-status-screening"> </a>  <a href="CodeSystem-research-subject-status.html#research-subject-status-screening">screening</a></td><td>http://hl7.org/fhir/research-subject-status</td><td>Screening</td><td><div><p>A person who is being evaluated for eligibility for a study.</p>
</div></td></tr></table></div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
    <extension url="packageId">
      <valueId value="hl7.fhir.uv.xver-r4b.r5"/>
    </extension>
    <extension url="version">
      <valueString value="0.0.1-snapshot-2"/>
    </extension>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical value="http://hl7.org/fhir/4.3/ImplementationGuide/hl7.fhir.uv.xver-r4b.r5"/>
      </extension>
    </valueCode>
  </extension>
  <url value="http://hl7.org/fhir/4.3/ValueSet/R4B-research-subject-status-for-R5"/>
  <version value="0.0.1-snapshot-2"/>
  <name value="R4B_research_subject_status_for_R5"/>
  <title value="Cross-version VS for R4B.ResearchSubjectStatus for use in FHIR R5"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-09-01T22:36:43.198877+10:00"/>
  <publisher value="Biomedical Research and Regulation"/>
  <contact>
    <name value="Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description value="This cross-version ValueSet represents concepts from http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 for use in FHIR R5. Concepts not present here have direct `equivalent` mappings crossing all versions from R4B to R5."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <concept>
        <code value="candidate"/>
        <display value="Candidate"/>
      </concept>
      <concept>
        <code value="eligible"/>
        <display value="Eligible"/>
      </concept>
      <concept>
        <code value="follow-up"/>
        <display value="Follow-up"/>
      </concept>
      <concept>
        <code value="ineligible"/>
        <display value="Ineligible"/>
      </concept>
      <concept>
        <code value="not-registered"/>
        <display value="Not Registered"/>
      </concept>
      <concept>
        <code value="off-study"/>
        <display value="Off-study"/>
      </concept>
      <concept>
        <code value="on-study"/>
        <display value="On-study"/>
      </concept>
      <concept>
        <code value="on-study-intervention"/>
        <display value="On-study-intervention"/>
      </concept>
      <concept>
        <code value="on-study-observation"/>
        <display value="On-study-observation"/>
      </concept>
      <concept>
        <code value="pending-on-study"/>
        <display value="Pending on-study"/>
      </concept>
      <concept>
        <code value="potential-candidate"/>
        <display value="Potential Candidate"/>
      </concept>
      <concept>
        <code value="screening"/>
        <display value="Screening"/>
      </concept>
    </include>
  </compose>
  <expansion>
    <timestamp value="2025-09-01T22:36:43.198878+10:00"/>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="candidate"/>
      <display value="Candidate"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="eligible"/>
      <display value="Eligible"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="follow-up"/>
      <display value="Follow-up"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="ineligible"/>
      <display value="Ineligible"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="not-registered"/>
      <display value="Not Registered"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="off-study"/>
      <display value="Off-study"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="on-study"/>
      <display value="On-study"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="on-study-intervention"/>
      <display value="On-study-intervention"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="on-study-observation"/>
      <display value="On-study-observation"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="pending-on-study"/>
      <display value="Pending on-study"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="potential-candidate"/>
      <display value="Potential Candidate"/>
    </contains>
    <contains>
      <system value="http://hl7.org/fhir/research-subject-status"/>
      <version value="4.3.0"/>
      <code value="screening"/>
      <display value="Screening"/>
    </contains>
  </expansion>
</ValueSet>