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 - JSON Representation

Page standards status: Informative

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{
  "resourceType" : "CodeSystem",
  "id" : "fda-add-seriousness-criteria-cs",
  "text" : {
    "status" : "generated",
    "div" : "<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>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "informative",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs",
  "version" : "1.0.0-ballot",
  "name" : "FDAaddSeriousnessCriteriaCS",
  "title" : "FDA Additional Seriousness Criteria CodeSystem",
  "status" : "draft",
  "experimental" : true,
  "date" : "2023-07-28T19:53:38+00:00",
  "publisher" : "HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups",
  "contact" : [
    {
      "name" : "Biomedical Research and Regulation WG",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description" : "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" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001"
        }
      ]
    }
  ],
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 1,
  "concept" : [
    {
      "code" : "requiresPreventImpairment",
      "display" : "Required Intervention to Prevent Permanent Impairment or Damage (Devices)",
      "definition" : "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"
    }
  ]
}