This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

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: Adverse Event Seriousness Criteria - XML Representation

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="adverse-event-seriousness-criteria-vs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C48275</td><td>Results In Death</td></tr><tr><td>C84266</td><td>Is Life Threatening</td></tr><tr><td>C83052</td><td>Requires Inpatient Hospitalization</td></tr><tr><td>C11338</td><td>Results In Persistent Or Significant Disability</td></tr><tr><td>C83117</td><td>Congenital Anomaly or Birth Defect</td></tr><tr><td>C82521</td><td>Other Medically Important Condition</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="informative">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-seriousness-criteria-vs"/>
  <version value="1.0.0-ballot"/>
  <name value="AdverseEventSerCrit"/>
  <title value="Adverse Event Seriousness Criteria"/>
  <status value="draft"/>
  <experimental value="true"/>
  <date value="2023-07-28T19:53:38+00:00"/>
  <publisher
             value="HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups"/>
  <contact>
    <name value="Biomedical Research and Regulation WG"/>
    <telecom>
      <system value="url"/>
      <value value="http://hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description
               value="Action criteria usually associated with serious events that pose a threat to a patient's life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C48275"/>
        <display value="Results In Death"/>
      </concept>
      <concept>
        <code value="C84266"/>
        <display value="Is Life Threatening"/>
      </concept>
      <concept>
        <code value="C83052"/>
        <display value="Requires Inpatient Hospitalization"/>
      </concept>
      <concept>
        <code value="C11338"/>
        <display value="Results In Persistent Or Significant Disability"/>
      </concept>
      <concept>
        <code value="C83117"/>
        <display value="Congenital Anomaly or Birth Defect"/>
      </concept>
      <concept>
        <code value="C82521"/>
        <display value="Other Medically Important Condition"/>
      </concept>
    </include>
  </compose>
</ValueSet>