<?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>