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

: Adverse Event Clinical Research Outcomes - JSON Representation

Page standards status: Informative

Raw json | Download


{
  "resourceType" : "ValueSet",
  "id" : "adverse-event-outcome-clinical-research-vs",
  "text" : {
    "status" : "generated",
    "div" : "<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>Fatal</td></tr><tr><td>C49494</td><td>Not recovering/not resolved</td></tr><tr><td>C49495</td><td>Recovered/Resolved with sequelae</td></tr><tr><td>C49498</td><td>Recovered/Resolved</td></tr><tr><td>C49496</td><td>Recovering/Resolving</td></tr></table></li></ul></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/ValueSet/adverse-event-outcome-clinical-research-vs",
  "version" : "1.0.0-ballot",
  "name" : "OutcomeAEClinRes",
  "title" : "Adverse Event Clinical Research Outcomes",
  "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" : "This value set includes codes that describe the type of outcome from the adverse event as typically used in reporting for Clinical Research, post-market surveillance (e.g. Medwatch forms). NCI codes used here This list originates from the ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf), specifically CDISC CL.C66768.OUT. 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" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept" : [
          {
            "code" : "C48275",
            "display" : "Fatal"
          },
          {
            "code" : "C49494",
            "display" : "Not recovering/not resolved"
          },
          {
            "code" : "C49495",
            "display" : "Recovered/Resolved with sequelae"
          },
          {
            "code" : "C49498",
            "display" : "Recovered/Resolved"
          },
          {
            "code" : "C49496",
            "display" : "Recovering/Resolving"
          }
        ]
      }
    ]
  }
}