{"caseSensitive":true,"concept":[{"code":"adverseEvent","definition":"adverse event.","display":"adverse event"},{"code":"death","definition":"death (adverse event).","display":"death (adverse event)"},{"code":"notEligible","definition":"did not meet eligibility criteria.","display":"did not meet eligibility criteria"},{"code":"eligibleButNo","definition":"eligible but unwilling or unable to participate.","display":"eligible but unwilling or unable to participate"},{"code":"enrolled","definition":"enrolled or registered.","display":"enrolled or registered"},{"code":"exclusion","definition":"exclusion.","display":"exclusion"},{"code":"followUpComplete","definition":"follow-up complete.","display":"follow-up complete"},{"code":"inclusion","definition":"inclusion.","display":"inclusion"},{"code":"informedConsentSigned","definition":"Informed consent signed.","display":"Informed consent signed"},{"code":"intOrObsComplete","definition":"intervention or observation complete.","display":"intervention or observation complete"},{"code":"nonCompliance","definition":"non-compliance.","display":"non-compliance"},{"code":"preReg","definition":"pre-registered or slot reserved.","display":"pre-registered or slot reserved"},{"code":"refuseConsent","definition":"refuse consent.","display":"refuse consent"},{"code":"screenFailure","definition":"screen failure.","display":"screen failure"},{"code":"studyClosed","definition":"study permanently closed to accrual.","display":"study permanently closed to accrual"},{"code":"studyTerminated","definition":"study terminated.","display":"study terminated"},{"code":"subjectRefusal","definition":"subject refusal.","display":"subject refusal"},{"code":"unwillingOrUnable","definition":"unwilling or unable to participate.","display":"unwilling or unable to participate"},{"code":"withdrawnConsent","definition":"withdrawn consent.","display":"withdrawn consent"},{"code":"diseaseRelapse","definition":"Relapse of disease.","display":"Disease Relapse"},{"code":"failedRandomization","definition":"Subject failed randomization.","display":"Failed Randomization"},{"code":"lackOfEfficacy","definition":"The study activities were not efficient in dealing with the underlying issue.","display":"Lack Of Efficacy"},{"code":"lostToFollowUp","definition":"The subject can no longer be followed up.","display":"Lost To Follow Up"},{"code":"physicianDecision","definition":"A physician has decided the subject should no longer continue on the study.","display":"Physician Decision"},{"code":"pregnancy","definition":"Subject is now pregnant and no longer meets the inclusion criteria.","display":"Pregnancy"},{"code":"progressiveDisease","definition":"The subject has a disease that has progressed to far to allow them to continue in the study.","display":"Progressive Disease"},{"code":"protocolDeviation","definition":"There has been a protocol deviation that cannot be corrected or compensated for.","display":"Protocol Deviation"},{"code":"recovery","definition":"The subject has recovered and no longer meets the inclusion criteria.","display":"Recovery"},{"code":"siteTerminated","definition":"The site where the subject was being treated is no longer in the study.","display":"Site Terminated"},{"code":"technicalProblems","definition":"The subject cannot continue on the study due to technical issues.","display":"Technical Problems"},{"code":"complete","definition":"The study is now complete.","display":"Complete"}],"contact":[{"telecom":[{"system":"url","value":"http://hl7.org/fhir"},{"system":"email","value":"fhir@lists.hl7.org"}]}],"content":"complete","date":"2020-12-28T16:55:11+11:00","description":"Indicates why the state of the subject changed.","experimental":false,"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}],"id":"state-change-reason","identifier":[{"system":"urn:ietf:rfc:3986","value":"urn:oid:2.16.840.1.113883.4.642.1.1477"}],"meta":{"lastUpdated":"2021-04-15T13:25:09.461+11:00","profile":["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]},"name":"StateChangeReason","publisher":"HL7 (FHIR Project)","resourceType":"CodeSystem","status":"draft","text":{"div":"

This code system http://terminology.hl7.org/CodeSystem/state-change-reason defines the following codes:

CodeDisplayDefinition
adverseEvent adverse eventadverse event.
death death (adverse event)death (adverse event).
notEligible did not meet eligibility criteriadid not meet eligibility criteria.
eligibleButNo eligible but unwilling or unable to participateeligible but unwilling or unable to participate.
enrolled enrolled or registeredenrolled or registered.
exclusion exclusionexclusion.
followUpComplete follow-up completefollow-up complete.
inclusion inclusioninclusion.
informedConsentSigned Informed consent signedInformed consent signed.
intOrObsComplete intervention or observation completeintervention or observation complete.
nonCompliance non-compliancenon-compliance.
preReg pre-registered or slot reservedpre-registered or slot reserved.
refuseConsent refuse consentrefuse consent.
screenFailure screen failurescreen failure.
studyClosed study permanently closed to accrualstudy permanently closed to accrual.
studyTerminated study terminatedstudy terminated.
subjectRefusal subject refusalsubject refusal.
unwillingOrUnable unwilling or unable to participateunwilling or unable to participate.
withdrawnConsent withdrawn consentwithdrawn consent.
diseaseRelapse Disease RelapseRelapse of disease.
failedRandomization Failed RandomizationSubject failed randomization.
lackOfEfficacy Lack Of EfficacyThe study activities were not efficient in dealing with the underlying issue.
lostToFollowUp Lost To Follow UpThe subject can no longer be followed up.
physicianDecision Physician DecisionA physician has decided the subject should no longer continue on the study.
pregnancy PregnancySubject is now pregnant and no longer meets the inclusion criteria.
progressiveDisease Progressive DiseaseThe subject has a disease that has progressed to far to allow them to continue in the study.
protocolDeviation Protocol DeviationThere has been a protocol deviation that cannot be corrected or compensated for.
recovery RecoveryThe subject has recovered and no longer meets the inclusion criteria.
siteTerminated Site TerminatedThe site where the subject was being treated is no longer in the study.
technicalProblems Technical ProblemsThe subject cannot continue on the study due to technical issues.
complete CompleteThe study is now complete.
","status":"generated"},"title":"StateChangeReason","url":"http://terminology.hl7.org/CodeSystem/state-change-reason","valueSet":"http://hl7.org/fhir/ValueSet/state-change-reason","version":"4.6.0"}