R5 Final QA

This page is part of the FHIR Specification (v5.0.0-draft-final: Final QA Preview for R5 - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

4.3.2.328 CodeSystem http://terminology.hl7.org/CodeSystem/state-change-reason

Biomedical Research and Regulation icon Work Group Maturity Level: 1Draft Use Context: Country: World
Official URL: http://terminology.hl7.org/CodeSystem/state-change-reason Version: 5.0.0-draft-final
active as of 2020-12-28 Computable Name: StateChangeReason
Flags: CaseSensitive, Complete. All codes ValueSet: State Change Reason OID: 2.16.840.1.113883.4.642.4.2009

This Code system is used in the following value sets:

4.3.2.328.1 Definition

Indicates why the state of the subject changed.

4.3.2.328.2 Content

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

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withdrawnConsent withdrawn consentwithdrawn consent.btn btn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

 

See the full registry of code systems defined as part of FHIR.

Explanation of the columns that may appear on this page:

LevelA few code lists that FHIR defines are hierarchical - each code is assigned a level. See Code System for further information.
SourceThe source of the definition of the code (when the value set draws in codes defined elsewhere)
CodeThe code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
DisplayThe display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
DefinitionAn explanation of the meaning of the concept
CommentsAdditional notes about how to use the code