Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - 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

4.4.1.336 ValueSet http://hl7.org/fhir/ValueSet/state-change-reason

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

This is a value set defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/ValueSet/state-change-reason
Version:5.0.0-ballot
Name:StateChangeReason
Title:StateChangeReason
Status:draft
Definition:

Indicates why the state of the subject changed.

Committee:Biomedical Research and Regulation icon Work Group
OID:2.16.840.1.113883.4.642.3.3130 (for OID based terminology systems)
Flags:Experimental, Immutable

This value set is used in the following places:

4.4.1.336.1 Content Logical Definition

 

4.4.1.336.2 Expansion

This expansion generated 10 Sep 2022

This value set contains 31 concepts

Expansion based on StateChangeReason v5.0.0-ballot (CodeSystem)

CodeSystemDisplayDefinition
  adverseEventhttp://terminology.hl7.org/CodeSystem/state-change-reasonadverse event

adverse event.

  deathhttp://terminology.hl7.org/CodeSystem/state-change-reasondeath (adverse event)

death (adverse event).

  notEligiblehttp://terminology.hl7.org/CodeSystem/state-change-reasondid not meet eligibility criteria

did not meet eligibility criteria.

  eligibleButNohttp://terminology.hl7.org/CodeSystem/state-change-reasoneligible but unwilling or unable to participate

eligible but unwilling or unable to participate.

  enrolledhttp://terminology.hl7.org/CodeSystem/state-change-reasonenrolled or registered

enrolled or registered.

  exclusionhttp://terminology.hl7.org/CodeSystem/state-change-reasonexclusion

exclusion.

  followUpCompletehttp://terminology.hl7.org/CodeSystem/state-change-reasonfollow-up complete

follow-up complete.

  inclusionhttp://terminology.hl7.org/CodeSystem/state-change-reasoninclusion

inclusion.

  informedConsentSignedhttp://terminology.hl7.org/CodeSystem/state-change-reasonInformed consent signed

Informed consent signed.

  intOrObsCompletehttp://terminology.hl7.org/CodeSystem/state-change-reasonintervention or observation complete

intervention or observation complete.

  nonCompliancehttp://terminology.hl7.org/CodeSystem/state-change-reasonnon-compliance

non-compliance.

  preReghttp://terminology.hl7.org/CodeSystem/state-change-reasonpre-registered or slot reserved

pre-registered or slot reserved.

  refuseConsenthttp://terminology.hl7.org/CodeSystem/state-change-reasonrefuse consent

refuse consent.

  screenFailurehttp://terminology.hl7.org/CodeSystem/state-change-reasonscreen failure

screen failure.

  studyClosedhttp://terminology.hl7.org/CodeSystem/state-change-reasonstudy permanently closed to accrual

study permanently closed to accrual.

  studyTerminatedhttp://terminology.hl7.org/CodeSystem/state-change-reasonstudy terminated

study terminated.

  subjectRefusalhttp://terminology.hl7.org/CodeSystem/state-change-reasonsubject refusal

subject refusal.

  unwillingOrUnablehttp://terminology.hl7.org/CodeSystem/state-change-reasonunwilling or unable to participate

unwilling or unable to participate.

  withdrawnConsenthttp://terminology.hl7.org/CodeSystem/state-change-reasonwithdrawn consent

withdrawn consent.

  diseaseRelapsehttp://terminology.hl7.org/CodeSystem/state-change-reasonDisease Relapse

Relapse of disease.

  failedRandomizationhttp://terminology.hl7.org/CodeSystem/state-change-reasonFailed Randomization

Subject failed randomization.

  lackOfEfficacyhttp://terminology.hl7.org/CodeSystem/state-change-reasonLack Of Efficacy

The study activities were not efficient in dealing with the underlying issue.

  lostToFollowUphttp://terminology.hl7.org/CodeSystem/state-change-reasonLost To Follow Up

The subject can no longer be followed up.

  physicianDecisionhttp://terminology.hl7.org/CodeSystem/state-change-reasonPhysician Decision

A physician has decided the subject should no longer continue on the study.

  pregnancyhttp://terminology.hl7.org/CodeSystem/state-change-reasonPregnancy

Subject is now pregnant and no longer meets the inclusion criteria.

  progressiveDiseasehttp://terminology.hl7.org/CodeSystem/state-change-reasonProgressive Disease

The subject has a disease that has progressed to far to allow them to continue in the study.

  protocolDeviationhttp://terminology.hl7.org/CodeSystem/state-change-reasonProtocol Deviation

There has been a protocol deviation that cannot be corrected or compensated for.

  recoveryhttp://terminology.hl7.org/CodeSystem/state-change-reasonRecovery

The subject has recovered and no longer meets the inclusion criteria.

  siteTerminatedhttp://terminology.hl7.org/CodeSystem/state-change-reasonSite Terminated

The site where the subject was being treated is no longer in the study.

  technicalProblemshttp://terminology.hl7.org/CodeSystem/state-change-reasonTechnical Problems

The subject cannot continue on the study due to technical issues.

  completehttp://terminology.hl7.org/CodeSystem/state-change-reasonComplete

The 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