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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemStateChangeReason
{ "resourceType" : "CodeSystem", "id" : "state-change-reason", "meta" : { "lastUpdated" : "2022-09-10T05:52:37.223+11:00", "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"] }, "text" : { "status" : "generated", "div" : "<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>" }, "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "brr" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode" : "draft" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger" : 1 }], "url" : "http://terminology.hl7.org/CodeSystem/state-change-reason", "identifier" : [{ "system" : "urn:ietf:rfc:3986", "value" : "urn:oid:2.16.840.1.113883.4.642.4.2009" }], "version" : "5.0.0-ballot", "name" : "StateChangeReason", "title" : "StateChangeReason", "status" : "draft", "experimental" : false, "date" : "2020-12-28T16:55:11+11:00", "publisher" : "HL7 (FHIR Project)", "contact" : [{ "telecom" : [{ "system" : "url", "value" : "http://hl7.org/fhir" }, { "system" : "email", "value" : "fhir@lists.hl7.org" }] }], "description" : "Indicates why the state of the subject changed.", "caseSensitive" : true, "valueSet" : "http://hl7.org/fhir/ValueSet/state-change-reason", "content" : "complete", "concept" : [{ "code" : "adverseEvent", "display" : "adverse event", "definition" : "adverse event." }, { "code" : "death", "display" : "death (adverse event)", "definition" : "death (adverse event)." }, { "code" : "notEligible", "display" : "did not meet eligibility criteria", "definition" : "did not meet eligibility criteria." }, { "code" : "eligibleButNo", "display" : "eligible but unwilling or unable to participate", "definition" : "eligible but unwilling or unable to participate." }, { "code" : "enrolled", "display" : "enrolled or registered", "definition" : "enrolled or registered." }, { "code" : "exclusion", "display" : "exclusion", "definition" : "exclusion." }, { "code" : "followUpComplete", "display" : "follow-up complete", "definition" : "follow-up complete." }, { "code" : "inclusion", "display" : "inclusion", "definition" : "inclusion." }, { "code" : "informedConsentSigned", "display" : "Informed consent signed", "definition" : "Informed consent signed." }, { "code" : "intOrObsComplete", "display" : "intervention or observation complete", "definition" : "intervention or observation complete." }, { "code" : "nonCompliance", "display" : "non-compliance", "definition" : "non-compliance." }, { "code" : "preReg", "display" : "pre-registered or slot reserved", "definition" : "pre-registered or slot reserved." }, { "code" : "refuseConsent", "display" : "refuse consent", "definition" : "refuse consent." }, { "code" : "screenFailure", "display" : "screen failure", "definition" : "screen failure." }, { "code" : "studyClosed", "display" : "study permanently closed to accrual", "definition" : "study permanently closed to accrual." }, { "code" : "studyTerminated", "display" : "study terminated", "definition" : "study terminated." }, { "code" : "subjectRefusal", "display" : "subject refusal", "definition" : "subject refusal." }, { "code" : "unwillingOrUnable", "display" : "unwilling or unable to participate", "definition" : "unwilling or unable to participate." }, { "code" : "withdrawnConsent", "display" : "withdrawn consent", "definition" : "withdrawn consent." }, { "code" : "diseaseRelapse", "display" : "Disease Relapse", "definition" : "Relapse of disease." }, { "code" : "failedRandomization", "display" : "Failed Randomization", "definition" : "Subject failed randomization." }, { "code" : "lackOfEfficacy", "display" : "Lack Of Efficacy", "definition" : "The study activities were not efficient in dealing with the underlying issue." }, { "code" : "lostToFollowUp", "display" : "Lost To Follow Up", "definition" : "The subject can no longer be followed up." }, { "code" : "physicianDecision", "display" : "Physician Decision", "definition" : "A physician has decided the subject should no longer continue on the study." }, { "code" : "pregnancy", "display" : "Pregnancy", "definition" : "Subject is now pregnant and no longer meets the inclusion criteria." }, { "code" : "progressiveDisease", "display" : "Progressive Disease", "definition" : "The subject has a disease that has progressed to far to allow them to continue in the study." }, { "code" : "protocolDeviation", "display" : "Protocol Deviation", "definition" : "There has been a protocol deviation that cannot be corrected or compensated for." }, { "code" : "recovery", "display" : "Recovery", "definition" : "The subject has recovered and no longer meets the inclusion criteria." }, { "code" : "siteTerminated", "display" : "Site Terminated", "definition" : "The site where the subject was being treated is no longer in the study." }, { "code" : "technicalProblems", "display" : "Technical Problems", "definition" : "The subject cannot continue on the study due to technical issues." }, { "code" : "complete", "display" : "Complete", "definition" : "The study is now complete." }] }
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.
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Sat, Sep 10, 2022 04:55+1000.
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