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Packagehl7.fhir.uv.ae-research-backport-ig.r4b
Resource TypeValueSet
IdValueSet-adverse-event-outcome-clinical-research-vs.json
FHIR VersionR4B
Sourcehttp://hl7.org/fhir/uv/ae-research-backport-ig/2023Sep/ValueSet-adverse-event-outcome-clinical-research-vs.html
URLhttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-outcome-clinical-research-vs
Version1.0.0-ballot
Statusdraft
Date2023-07-28T19:53:38+00:00
NameOutcomeAEClinRes
TitleAdverse Event Clinical Research Outcomes
Realmuv
Authorityhl7
DescriptionThis 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.

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Resources that this resource uses

CodeSystem
Thesaurus.owlNCI Thesaurus

Narrative

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Source1

{
  "resourceType": "ValueSet",
  "id": "adverse-event-outcome-clinical-research-vs",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "informative",
      "_valueCode": {
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            "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"
          }
        ]
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    }
  ],
  "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": [
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          "system": "url",
          "value": "http://hl7.org/Special/committees/rcrim"
        }
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  ],
  "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.",
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        "concept": [
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            "code": "C48275",
            "display": "Fatal"
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            "display": "Not recovering/not resolved"
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            "display": "Recovered/Resolved"
          },
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}