Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

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

: FDA Additional Seriousness Criteria CodeSystem - XML Representation

Page standards status: Informative

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="fda-add-seriousness-criteria-cs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This code system <code>http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs</code> defines the following code:</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">requiresPreventImpairment<a name="fda-add-seriousness-criteria-cs-requiresPreventImpairment"> </a></td><td>Required Intervention to Prevent Permanent Impairment or Damage (Devices)</td><td>Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product</td></tr></table></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/CodeSystem/fda-add-seriousness-criteria-cs"/>
  <version value="1.0.0-ballot"/>
  <name value="FDAaddSeriousnessCriteriaCS"/>
  <title value="FDA Additional Seriousness Criteria CodeSystem"/>
  <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="Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch)."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="1"/>
  <concept>
    <code value="requiresPreventImpairment"/>
    <display
             value="Required Intervention to Prevent Permanent Impairment or Damage (Devices)"/>
    <definition
                value="Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product"/>
  </concept>
</CodeSystem>