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Codesystem-research-subject-status.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

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Definition for Code System ResearchSubjectStatus

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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-subject-status"/> 
  <meta> 
    <lastUpdated value="2019-09-21T00:52:31.458+00:00"/> 
  </meta> 
  <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 &quot;short-term follow-up&quot;.</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-wg">
    <valueCode value="brr"/> 
  </extension> 
  <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="0"/> 
  </extension> 
  <url value="http://hl7.org/fhir/research-subject-status"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.830"/> 
  </identifier> 
  <version value="4.1.0"/> 
  <name value="ResearchSubjectStatus"/> 
  <title value="ResearchSubjectStatus"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2019-09-21T00:52:31+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://hl7.org/fhir/ValueSet/research-subject-status"/> 
  <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> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.