Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Codesystem-state-change-reason.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw JSON (canonical form + also see JSON Format Specification)

Definition for Code System StateChangeReason

{
  "resourceType" : "CodeSystem",
  "id" : "state-change-reason",
  "meta" : {
    "lastUpdated" : "2021-04-15T13:25:09.461+11:00",
    "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div>!-- Snipped for Brevity --></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:2.16.840.1.113883.4.642.1.1477"
  }],
  "version" : "4.6.0",
  "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.