This page is part of the HL7 Terminology (v1.0.0: Release) based on FHIR R4. The current version which supercedes this version is 5.2.0. For a full list of available versions, see the Directory of published versions

ResearchSubjectState - XML Representation

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<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">
            
      <h2>ResearchSubjectState</h2>
            
      <div>
              
        <p>Indicates the progression of a study subject through a study.</p>

            
      </div>
            
      <p>This code system http://terminology.hl7.org/CodeSystem/research-subject-state 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>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-state-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-state-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-state-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-state-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-state-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-state-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-state-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-state-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 &quot;short-term follow-up&quot;.</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>A person is pre-registered for a study.</td>
              
        </tr>
              
        <tr>
                
          <td style="white-space:nowrap">potential-candidate
                  
            <a name="research-subject-state-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-state-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-state-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-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="draft"/>
  </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="4.2.0"/>
  <name value="ResearchSubjectState"/>
  <title value="ResearchSubjectState"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2020-04-09T21:10:28+00:00"/>
  <publisher value="HL7 (FHIR Project)"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://hl7.org/fhir"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="fhir@lists.hl7.org"/>
    </telecom>
  </contact>
  <description
               value="Indicates the progression of a study subject through a study."/>
  <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 &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>