Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-subject-status"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<h2>ResearchSubjectStatus</h2>
<div>
<p>Indicates the progression of a study subject through a study.</p>
</div>
<p>This code system http://hl7.org/fhir/research-subject-status 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-status-candidate"> </a>
</td>
<td>Candidate</td>
<td>An identified person that can be considered for inclusion in a study.</td>
</tr>
<tr>
<td style="white-space:nowrap">eligible
<a name="research-subject-status-eligible"> </a>
</td>
<td>Eligible</td>
<td>A person that has met the eligibility criteria for inclusion in a study.</td>
</tr>
<tr>
<td style="white-space:nowrap">follow-up
<a name="research-subject-status-follow-up"> </a>
</td>
<td>Follow-up</td>
<td>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.</td>
</tr>
<tr>
<td style="white-space:nowrap">ineligible
<a name="research-subject-status-ineligible"> </a>
</td>
<td>Ineligible</td>
<td>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.</td>
</tr>
<tr>
<td style="white-space:nowrap">not-registered
<a name="research-subject-status-not-registered"> </a>
</td>
<td>Not Registered</td>
<td>A person for whom registration was not completed.</td>
</tr>
<tr>
<td style="white-space:nowrap">off-study
<a name="research-subject-status-off-study"> </a>
</td>
<td>Off-study</td>
<td>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.</td>
</tr>
<tr>
<td style="white-space:nowrap">on-study
<a name="research-subject-status-on-study"> </a>
</td>
<td>On-study</td>
<td>A person that is enrolled or registered on a study.</td>
</tr>
<tr>
<td style="white-space:nowrap">on-study-intervention
<a name="research-subject-status-on-study-intervention"> </a>
</td>
<td>On-study-intervention</td>
<td>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</td>
</tr>
<tr>
<td style="white-space:nowrap">on-study-observation
<a name="research-subject-status-on-study-observation"> </a>
</td>
<td>On-study-observation</td>
<td>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".</td>
</tr>
<tr>
<td style="white-space:nowrap">pending-on-study
<a name="research-subject-status-pending-on-study"> </a>
</td>
<td>Pending on-study</td>
<td>A person is pre-registered for a study.</td>
</tr>
<tr>
<td style="white-space:nowrap">potential-candidate
<a name="research-subject-status-potential-candidate"> </a>
</td>
<td>Potential Candidate</td>
<td>A person that is potentially eligible for participation in the study.</td>
</tr>
<tr>
<td style="white-space:nowrap">screening
<a name="research-subject-status-screening"> </a>
</td>
<td>Screening</td>
<td>A person who is being evaluated for eligibility for a study.</td>
</tr>
<tr>
<td style="white-space:nowrap">withdrawn
<a name="research-subject-status-withdrawn"> </a>
</td>
<td>Withdrawn</td>
<td>The person has withdrawn their participation in the study before registration.</td>
</tr>
</table>
</div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="trial-use"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r4b.r3"/>
</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.r3"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url value="http://hl7.org/fhir/research-subject-status"/>
<version value="4.3.0"/>
<name value="ResearchSubjectStatus"/>
<title value="ResearchSubjectStatus"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2021-01-16T14:06:13-06:00"/>
<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="Indicates the progression of a study subject through a study."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<caseSensitive value="true"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-subject-status|3.0.2"/>
<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 © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r4b.r3#0.1.0 based on FHIR 3.0.2. Generated 2026-03-20
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