Extensions for Using Data Elements from FHIR R4B in FHIR R5 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="R4B-research-subject-status-for-R5-publication-status"/>
<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-publication-status</b></p><a name="R4B-research-subject-status-for-R5-publication-status"> </a><a name="hcR4B-research-subject-status-for-R5-publication-status"> </a><p>This value set expansion contains 12 concepts.</p><table class="codes"><tr><td><b>System</b></td><td><b>Version</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-candidate"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-candidate">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-eligible"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-eligible">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-follow-up"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-follow-up">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-ineligible"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-ineligible">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-not-registered"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-not-registered">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-off-study"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-off-study">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-on-study"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-on-study-intervention"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study-intervention">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-on-study-observation"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-on-study-observation">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-pending-on-study"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-pending-on-study">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-potential-candidate"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-potential-candidate">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><a name="R4B-research-subject-status-for-R5-publication-status-http://hl7.org/fhir/research-subject-status-screening"> </a><code>http://hl7.org/fhir/research-subject-status</code></td><td>4.3.0</td><td style="white-space:nowrap"> <a href="CodeSystem-research-subject-status.html#research-subject-status-screening">screening</a></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="0.1.0"/>
</extension>
<extension url="uri">
<valueUri
value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r5"/>
</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/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r5"/>
</extension>
</valueCode>
</extension>
<url
value="http://hl7.org/fhir/uv/xver/ValueSet/R4B-research-subject-status-for-R5-publication-status"/>
<version value="0.1.0"/>
<name value="R4BResearchSubjectStatusForR5PublicationStatus"/>
<title
value="Cross-version ValueSet R4B.ResearchSubjectStatus for use in FHIR R5"/>
<status value="active"/>
<experimental value="false"/>
<date value="2026-03-17T21:02:03.8104715+00:00"/>
<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 content from http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 for use in FHIR R5 that is appropriate for use but unavailable in `http://hl7.org/fhir/ValueSet/publication-status|5.0.0`."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="This value set is part of the cross-version definitions generated to enable use of the
value set `http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0` as defined in FHIR R4B
in FHIR R5.
The source value set is bound to the following FHIR R4B elements:
* `ResearchSubject.status`
The following concepts are not included in this cross-version definition because they have valid representations:
* `http://hl7.org/fhir/research-subject-status#withdrawn`
Following are the generation technical comments:
One or more source concepts are either not mapped or broader than their targets, so the value set relationship is broadened.
The source value set has more active concepts (13) than the target (4), so the source is broader than the target."/>
<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="2026-03-17T21:02:03.8104715+00:00"/>
<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>