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FHIR IG Statistics: ValueSet/adverse-event-clinical-research-outcomes

Packagehl7.terminology
TypeValueSet
Idadverse-event-clinical-research-outcomes
FHIR VersionR5
Sourcehttp://terminology.hl7.org/https://build.fhir.org/ig/HL7/UTG/ValueSet-adverse-event-clinical-research-outcomes.html
URLhttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes
Version1.0.0
Statusactive
Date2023-07-28T19:27:19+00:00
NameAdverseEventClinicalResearchOutcomes
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.
CopyrightThis material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html

Resources that use this resource

StructureDefinition
AdverseEvent-clinical-researchAdverse Event Clinical Research
AdverseEvent-clinical-researchAdverse Event Clinical Research

Resources that this resource uses

CodeSystem
Thesaurus.owlNCI Thesaurus
Thesaurus.owlNCI Thesaurus

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ValueSet adverse-event-clinical-research-outcomes


Source

{
  "resourceType": "ValueSet",
  "id": "adverse-event-clinical-research-outcomes",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/StructureDefinition/shareablevalueset"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1
    }
  ],
  "url": "http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes",
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:2.16.840.1.113883.11.21025"
    }
  ],
  "version": "1.0.0",
  "name": "AdverseEventClinicalResearchOutcomes",
  "title": "Adverse Event Clinical Research Outcomes",
  "status": "active",
  "experimental": false,
  "date": "2023-07-28T19:27:19+00:00",
  "publisher": "Health Level Seven International",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org"
        },
        {
          "system": "email",
          "value": "hq@HL7.org"
        }
      ]
    }
  ],
  "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.",
  "copyright": "This material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html",
  "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"
          }
        ]
      }
    ]
  }
}