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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="state-change-reason"/>
  <meta>
    <lastUpdated value="2022-12-14T07:12:54.019+11:00"/>
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>This code system 
        <code>http://terminology.hl7.org/CodeSystem/state-change-reason</code> 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">adverseEvent
            <a name="state-change-reason-adverseEvent"> </a>
          </td>
          <td>adverse event</td>
          <td>adverse event.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">death
            <a name="state-change-reason-death"> </a>
          </td>
          <td>death (adverse event)</td>
          <td>death (adverse event).</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">notEligible
            <a name="state-change-reason-notEligible"> </a>
          </td>
          <td>did not meet eligibility criteria</td>
          <td>did not meet eligibility criteria.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">eligibleButNo
            <a name="state-change-reason-eligibleButNo"> </a>
          </td>
          <td>eligible but unwilling or unable to participate</td>
          <td>eligible but unwilling or unable to participate.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">enrolled
            <a name="state-change-reason-enrolled"> </a>
          </td>
          <td>enrolled or registered</td>
          <td>enrolled or registered.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">exclusion
            <a name="state-change-reason-exclusion"> </a>
          </td>
          <td>exclusion</td>
          <td>exclusion.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">followUpComplete
            <a name="state-change-reason-followUpComplete"> </a>
          </td>
          <td>follow-up complete</td>
          <td>follow-up complete.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">inclusion
            <a name="state-change-reason-inclusion"> </a>
          </td>
          <td>inclusion</td>
          <td>inclusion.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">informedConsentSigned
            <a name="state-change-reason-informedConsentSigned"> </a>
          </td>
          <td>Informed consent signed</td>
          <td>Informed consent signed.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">intOrObsComplete
            <a name="state-change-reason-intOrObsComplete"> </a>
          </td>
          <td>intervention or observation complete</td>
          <td>intervention or observation complete.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">nonCompliance
            <a name="state-change-reason-nonCompliance"> </a>
          </td>
          <td>non-compliance</td>
          <td>non-compliance.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">preReg
            <a name="state-change-reason-preReg"> </a>
          </td>
          <td>pre-registered or slot reserved</td>
          <td>pre-registered or slot reserved.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">refuseConsent
            <a name="state-change-reason-refuseConsent"> </a>
          </td>
          <td>refuse consent</td>
          <td>refuse consent.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">screenFailure
            <a name="state-change-reason-screenFailure"> </a>
          </td>
          <td>screen failure</td>
          <td>screen failure.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">studyClosed
            <a name="state-change-reason-studyClosed"> </a>
          </td>
          <td>study permanently closed to accrual</td>
          <td>study permanently closed to accrual.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">studyTerminated
            <a name="state-change-reason-studyTerminated"> </a>
          </td>
          <td>study terminated</td>
          <td>study terminated.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">subjectRefusal
            <a name="state-change-reason-subjectRefusal"> </a>
          </td>
          <td>subject refusal</td>
          <td>subject refusal.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">unwillingOrUnable
            <a name="state-change-reason-unwillingOrUnable"> </a>
          </td>
          <td>unwilling or unable to participate</td>
          <td>unwilling or unable to participate.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">withdrawnConsent
            <a name="state-change-reason-withdrawnConsent"> </a>
          </td>
          <td>withdrawn consent</td>
          <td>withdrawn consent.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">diseaseRelapse
            <a name="state-change-reason-diseaseRelapse"> </a>
          </td>
          <td>Disease Relapse</td>
          <td>Relapse of disease.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">failedRandomization
            <a name="state-change-reason-failedRandomization"> </a>
          </td>
          <td>Failed Randomization</td>
          <td>Subject failed randomization.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">lackOfEfficacy
            <a name="state-change-reason-lackOfEfficacy"> </a>
          </td>
          <td>Lack Of Efficacy</td>
          <td>The study activities were not efficient in dealing with the underlying issue.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">lostToFollowUp
            <a name="state-change-reason-lostToFollowUp"> </a>
          </td>
          <td>Lost To Follow Up</td>
          <td>The subject can no longer be followed up.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">physicianDecision
            <a name="state-change-reason-physicianDecision"> </a>
          </td>
          <td>Physician Decision</td>
          <td>A physician has decided the subject should no longer continue on the study.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">pregnancy
            <a name="state-change-reason-pregnancy"> </a>
          </td>
          <td>Pregnancy</td>
          <td>Subject is now pregnant and no longer meets the inclusion criteria.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">progressiveDisease
            <a name="state-change-reason-progressiveDisease"> </a>
          </td>
          <td>Progressive Disease</td>
          <td>The subject has a disease that has progressed to far to allow them to continue in the study.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">protocolDeviation
            <a name="state-change-reason-protocolDeviation"> </a>
          </td>
          <td>Protocol Deviation</td>
          <td>There has been a protocol deviation that cannot be corrected or compensated for.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">recovery
            <a name="state-change-reason-recovery"> </a>
          </td>
          <td>Recovery</td>
          <td>The subject has recovered and no longer meets the inclusion criteria.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">siteTerminated
            <a name="state-change-reason-siteTerminated"> </a>
          </td>
          <td>Site Terminated</td>
          <td>The site where the subject was being treated is no longer in the study.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">technicalProblems
            <a name="state-change-reason-technicalProblems"> </a>
          </td>
          <td>Technical Problems</td>
          <td>The subject cannot continue on the study due to technical issues.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">complete
            <a name="state-change-reason-complete"> </a>
          </td>
          <td>Complete</td>
          <td>The study is now complete.</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/state-change-reason"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.4.2009"/>
  </identifier>
  <version value="5.0.0-snapshot3"/>
  <name value="StateChangeReason"/>
  <title value="StateChangeReason"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2020-12-28T16:55:11+11:00"/>
  <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 why the state of the subject changed."/>
  <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/state-change-reason"/>
  <content value="complete"/>
  <concept>
    <code value="adverseEvent"/>
    <display value="adverse event"/>
    <definition value="adverse event."/>
  </concept>
  <concept>
    <code value="death"/>
    <display value="death (adverse event)"/>
    <definition value="death (adverse event)."/>
  </concept>
  <concept>
    <code value="notEligible"/>
    <display value="did not meet eligibility criteria"/>
    <definition value="did not meet eligibility criteria."/>
  </concept>
  <concept>
    <code value="eligibleButNo"/>
    <display value="eligible but unwilling or unable to participate"/>
    <definition value="eligible but unwilling or unable to participate."/>
  </concept>
  <concept>
    <code value="enrolled"/>
    <display value="enrolled or registered"/>
    <definition value="enrolled or registered."/>
  </concept>
  <concept>
    <code value="exclusion"/>
    <display value="exclusion"/>
    <definition value="exclusion."/>
  </concept>
  <concept>
    <code value="followUpComplete"/>
    <display value="follow-up complete"/>
    <definition value="follow-up complete."/>
  </concept>
  <concept>
    <code value="inclusion"/>
    <display value="inclusion"/>
    <definition value="inclusion."/>
  </concept>
  <concept>
    <code value="informedConsentSigned"/>
    <display value="Informed consent signed"/>
    <definition value="Informed consent signed."/>
  </concept>
  <concept>
    <code value="intOrObsComplete"/>
    <display value="intervention or observation complete"/>
    <definition value="intervention or observation complete."/>
  </concept>
  <concept>
    <code value="nonCompliance"/>
    <display value="non-compliance"/>
    <definition value="non-compliance."/>
  </concept>
  <concept>
    <code value="preReg"/>
    <display value="pre-registered or slot reserved"/>
    <definition value="pre-registered or slot reserved."/>
  </concept>
  <concept>
    <code value="refuseConsent"/>
    <display value="refuse consent"/>
    <definition value="refuse consent."/>
  </concept>
  <concept>
    <code value="screenFailure"/>
    <display value="screen failure"/>
    <definition value="screen failure."/>
  </concept>
  <concept>
    <code value="studyClosed"/>
    <display value="study permanently closed to accrual"/>
    <definition value="study permanently closed to accrual."/>
  </concept>
  <concept>
    <code value="studyTerminated"/>
    <display value="study terminated"/>
    <definition value="study terminated."/>
  </concept>
  <concept>
    <code value="subjectRefusal"/>
    <display value="subject refusal"/>
    <definition value="subject refusal."/>
  </concept>
  <concept>
    <code value="unwillingOrUnable"/>
    <display value="unwilling or unable to participate"/>
    <definition value="unwilling or unable to participate."/>
  </concept>
  <concept>
    <code value="withdrawnConsent"/>
    <display value="withdrawn consent"/>
    <definition value="withdrawn consent."/>
  </concept>
  <concept>
    <code value="diseaseRelapse"/>
    <display value="Disease Relapse"/>
    <definition value="Relapse of disease."/>
  </concept>
  <concept>
    <code value="failedRandomization"/>
    <display value="Failed Randomization"/>
    <definition value="Subject failed randomization."/>
  </concept>
  <concept>
    <code value="lackOfEfficacy"/>
    <display value="Lack Of Efficacy"/>
    <definition value="The study activities were not efficient in dealing with the underlying issue."/>
  </concept>
  <concept>
    <code value="lostToFollowUp"/>
    <display value="Lost To Follow Up"/>
    <definition value="The subject can no longer be followed up."/>
  </concept>
  <concept>
    <code value="physicianDecision"/>
    <display value="Physician Decision"/>
    <definition value="A physician has decided the subject should no longer continue on the study."/>
  </concept>
  <concept>
    <code value="pregnancy"/>
    <display value="Pregnancy"/>
    <definition value="Subject is now pregnant and no longer meets the inclusion criteria."/>
  </concept>
  <concept>
    <code value="progressiveDisease"/>
    <display value="Progressive Disease"/>
    <definition value="The subject has a disease that has progressed to far to allow them to continue in the study."/>
  </concept>
  <concept>
    <code value="protocolDeviation"/>
    <display value="Protocol Deviation"/>
    <definition value="There has been a protocol deviation that cannot be corrected or compensated for."/>
  </concept>
  <concept>
    <code value="recovery"/>
    <display value="Recovery"/>
    <definition value="The subject has recovered and no longer meets the inclusion criteria."/>
  </concept>
  <concept>
    <code value="siteTerminated"/>
    <display value="Site Terminated"/>
    <definition value="The site where the subject was being treated is no longer in the study."/>
  </concept>
  <concept>
    <code value="technicalProblems"/>
    <display value="Technical Problems"/>
    <definition value="The subject cannot continue on the study due to technical issues."/>
  </concept>
  <concept>
    <code value="complete"/>
    <display value="Complete"/>
    <definition value="The study is now complete."/>
  </concept>
</CodeSystem>