Release 5 Draft Ballot

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See the Directory of published versions Value Set

Biomedical Research and Regulation Work Group Maturity Level: 1Draft Use Context: Not Intended for Production use

This is a value set defined by the FHIR project.


Defining URL:

Indicates why the state of the subject changed.

Committee:Biomedical Research and Regulation Work Group
OID:2.16.840.1.113883.4.642.3.1476 (for OID based terminology systems)
Source ResourceXML / JSON

This value set is used in the following places:


This expansion generated 29 May 2022

This value set contains 31 concepts

Expansion based on StateChangeReason v4.6.0 (CodeSystem)

All codes in this table are from the system

adverseEventadverse eventadverse event.
deathdeath (adverse event)death (adverse event).
notEligibledid not meet eligibility criteriadid not meet eligibility criteria.
eligibleButNoeligible but unwilling or unable to participateeligible but unwilling or unable to participate.
enrolledenrolled or registeredenrolled or registered.
followUpCompletefollow-up completefollow-up complete.
informedConsentSignedInformed consent signedInformed consent signed.
intOrObsCompleteintervention or observation completeintervention or observation complete.
preRegpre-registered or slot reservedpre-registered or slot reserved.
refuseConsentrefuse consentrefuse consent.
screenFailurescreen failurescreen failure.
studyClosedstudy permanently closed to accrualstudy permanently closed to accrual.
studyTerminatedstudy terminatedstudy terminated.
subjectRefusalsubject refusalsubject refusal.
unwillingOrUnableunwilling or unable to participateunwilling or unable to participate.
withdrawnConsentwithdrawn consentwithdrawn consent.
diseaseRelapseDisease RelapseRelapse of disease.
failedRandomizationFailed RandomizationSubject failed randomization.
lackOfEfficacyLack Of EfficacyThe study activities were not efficient in dealing with the underlying issue.
lostToFollowUpLost To Follow UpThe subject can no longer be followed up.
physicianDecisionPhysician DecisionA physician has decided the subject should no longer continue on the study.
pregnancyPregnancySubject is now pregnant and no longer meets the inclusion criteria.
progressiveDiseaseProgressive DiseaseThe subject has a disease that has progressed to far to allow them to continue in the study.
protocolDeviationProtocol DeviationThere has been a protocol deviation that cannot be corrected or compensated for.
recoveryRecoveryThe subject has recovered and no longer meets the inclusion criteria.
siteTerminatedSite TerminatedThe site where the subject was being treated is no longer in the study.
technicalProblemsTechnical ProblemsThe subject cannot continue on the study due to technical issues.
completeCompleteThe study is now complete.


See the full registry of value sets defined as part of FHIR.

Explanation of the columns that may appear on this page:

LvlA few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - 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