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

Example 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 SystemStateChangeReason

{
  "resourceType" : "CodeSystem",
  "id" : "state-change-reason",
  "meta" : {
    "lastUpdated" : "2022-09-10T05:52:37.223+11:00",
    "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://terminology.hl7.org/CodeSystem/state-change-reason</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">adverseEvent<a name=\"state-change-reason-adverseEvent\"> </a></td><td>adverse event</td><td>adverse event.</td></tr><tr><td style=\"white-space:nowrap\">death<a name=\"state-change-reason-death\"> </a></td><td>death (adverse event)</td><td>death (adverse event).</td></tr><tr><td style=\"white-space:nowrap\">notEligible<a name=\"state-change-reason-notEligible\"> </a></td><td>did not meet eligibility criteria</td><td>did not meet eligibility criteria.</td></tr><tr><td style=\"white-space:nowrap\">eligibleButNo<a name=\"state-change-reason-eligibleButNo\"> </a></td><td>eligible but unwilling or unable to participate</td><td>eligible but unwilling or unable to participate.</td></tr><tr><td style=\"white-space:nowrap\">enrolled<a name=\"state-change-reason-enrolled\"> </a></td><td>enrolled or registered</td><td>enrolled or registered.</td></tr><tr><td style=\"white-space:nowrap\">exclusion<a name=\"state-change-reason-exclusion\"> </a></td><td>exclusion</td><td>exclusion.</td></tr><tr><td style=\"white-space:nowrap\">followUpComplete<a name=\"state-change-reason-followUpComplete\"> </a></td><td>follow-up complete</td><td>follow-up complete.</td></tr><tr><td style=\"white-space:nowrap\">inclusion<a name=\"state-change-reason-inclusion\"> </a></td><td>inclusion</td><td>inclusion.</td></tr><tr><td style=\"white-space:nowrap\">informedConsentSigned<a name=\"state-change-reason-informedConsentSigned\"> </a></td><td>Informed consent signed</td><td>Informed consent signed.</td></tr><tr><td style=\"white-space:nowrap\">intOrObsComplete<a name=\"state-change-reason-intOrObsComplete\"> </a></td><td>intervention or observation complete</td><td>intervention or observation complete.</td></tr><tr><td style=\"white-space:nowrap\">nonCompliance<a name=\"state-change-reason-nonCompliance\"> </a></td><td>non-compliance</td><td>non-compliance.</td></tr><tr><td style=\"white-space:nowrap\">preReg<a name=\"state-change-reason-preReg\"> </a></td><td>pre-registered or slot reserved</td><td>pre-registered or slot reserved.</td></tr><tr><td style=\"white-space:nowrap\">refuseConsent<a name=\"state-change-reason-refuseConsent\"> </a></td><td>refuse consent</td><td>refuse consent.</td></tr><tr><td style=\"white-space:nowrap\">screenFailure<a name=\"state-change-reason-screenFailure\"> </a></td><td>screen failure</td><td>screen failure.</td></tr><tr><td style=\"white-space:nowrap\">studyClosed<a name=\"state-change-reason-studyClosed\"> </a></td><td>study permanently closed to accrual</td><td>study permanently closed to accrual.</td></tr><tr><td style=\"white-space:nowrap\">studyTerminated<a name=\"state-change-reason-studyTerminated\"> </a></td><td>study terminated</td><td>study terminated.</td></tr><tr><td style=\"white-space:nowrap\">subjectRefusal<a name=\"state-change-reason-subjectRefusal\"> </a></td><td>subject refusal</td><td>subject refusal.</td></tr><tr><td style=\"white-space:nowrap\">unwillingOrUnable<a name=\"state-change-reason-unwillingOrUnable\"> </a></td><td>unwilling or unable to participate</td><td>unwilling or unable to participate.</td></tr><tr><td style=\"white-space:nowrap\">withdrawnConsent<a name=\"state-change-reason-withdrawnConsent\"> </a></td><td>withdrawn consent</td><td>withdrawn consent.</td></tr><tr><td style=\"white-space:nowrap\">diseaseRelapse<a name=\"state-change-reason-diseaseRelapse\"> </a></td><td>Disease Relapse</td><td>Relapse of disease.</td></tr><tr><td style=\"white-space:nowrap\">failedRandomization<a name=\"state-change-reason-failedRandomization\"> </a></td><td>Failed Randomization</td><td>Subject failed randomization.</td></tr><tr><td style=\"white-space:nowrap\">lackOfEfficacy<a name=\"state-change-reason-lackOfEfficacy\"> </a></td><td>Lack Of Efficacy</td><td>The study activities were not efficient in dealing with the underlying issue.</td></tr><tr><td style=\"white-space:nowrap\">lostToFollowUp<a name=\"state-change-reason-lostToFollowUp\"> </a></td><td>Lost To Follow Up</td><td>The subject can no longer be followed up.</td></tr><tr><td style=\"white-space:nowrap\">physicianDecision<a name=\"state-change-reason-physicianDecision\"> </a></td><td>Physician Decision</td><td>A physician has decided the subject should no longer continue on the study.</td></tr><tr><td style=\"white-space:nowrap\">pregnancy<a name=\"state-change-reason-pregnancy\"> </a></td><td>Pregnancy</td><td>Subject is now pregnant and no longer meets the inclusion criteria.</td></tr><tr><td style=\"white-space:nowrap\">progressiveDisease<a name=\"state-change-reason-progressiveDisease\"> </a></td><td>Progressive Disease</td><td>The subject has a disease that has progressed to far to allow them to continue in the study.</td></tr><tr><td style=\"white-space:nowrap\">protocolDeviation<a name=\"state-change-reason-protocolDeviation\"> </a></td><td>Protocol Deviation</td><td>There has been a protocol deviation that cannot be corrected or compensated for.</td></tr><tr><td style=\"white-space:nowrap\">recovery<a name=\"state-change-reason-recovery\"> </a></td><td>Recovery</td><td>The subject has recovered and no longer meets the inclusion criteria.</td></tr><tr><td style=\"white-space:nowrap\">siteTerminated<a name=\"state-change-reason-siteTerminated\"> </a></td><td>Site Terminated</td><td>The site where the subject was being treated is no longer in the study.</td></tr><tr><td style=\"white-space:nowrap\">technicalProblems<a name=\"state-change-reason-technicalProblems\"> </a></td><td>Technical Problems</td><td>The subject cannot continue on the study due to technical issues.</td></tr><tr><td style=\"white-space:nowrap\">complete<a name=\"state-change-reason-complete\"> </a></td><td>Complete</td><td>The study is now complete.</td></tr></table></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:2.16.840.1.113883.4.642.4.2009"
  }],
  "version" : "5.0.0-ballot",
  "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.