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Resource ValueSet/FHIR Server from package hl7.terminology#current (47 ms)

Package hl7.terminology
Type ValueSet
Id Id
FHIR Version R5
Source http://terminology.hl7.org/https://build.fhir.org/ig/HL7/UTG/ValueSet-adverse-event-clinical-research-seriousness-criteria.html
Url http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria
Version 1.0.0
Status active
Date 2023-07-28T19:27:19+00:00
Name AdverseEventCRSerCrit
Title Adverse Event Clinical Research Seriousness Criteria
Experimental False
Realm uv
Authority hl7
Description Action criteria usually associated with serious events that pose a threat to a patient's life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). 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

Resources that use this resource

StructureDefinition
http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria Criteria reviewed in determining serious adverse event
http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria Criteria reviewed in determining serious adverse event

Resources that this resource uses

CodeSystem
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl NCI Thesaurus


Narrative

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

Generated Narrative: ValueSet adverse-event-clinical-research-seriousness-criteria

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C48275Results In Death
    C84266Is Life Threatening
    C83052Requires Inpatient Hospitalization
    C11338Results In Persistent Or Significant Disability
    C83117Congenital Anomaly or Birth Defect
    C82521Other Medically Important Condition
    C201939Required Intervention to Prevent Permanent Impairment/damage

Source

{
  "resourceType" : "ValueSet",
  "id" : "adverse-event-clinical-research-seriousness-criteria",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/StructureDefinition/shareablevalueset"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet adverse-event-clinical-research-seriousness-criteria</b></p><a name=\"adverse-event-clinical-research-seriousness-criteria\"> </a><a name=\"hcadverse-event-clinical-research-seriousness-criteria\"> </a><a name=\"adverse-event-clinical-research-seriousness-criteria-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"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>Results In Death</td></tr><tr><td>C84266</td><td>Is Life Threatening</td></tr><tr><td>C83052</td><td>Requires Inpatient Hospitalization</td></tr><tr><td>C11338</td><td>Results In Persistent Or Significant Disability</td></tr><tr><td>C83117</td><td>Congenital Anomaly or Birth Defect</td></tr><tr><td>C82521</td><td>Other Medically Important Condition</td></tr><tr><td>C201939</td><td>Required Intervention to Prevent Permanent Impairment/damage</td></tr></table></li></ul></div>"
  },
  "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-seriousness-criteria",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.11.21026"
    }
  ],
  "version" : "1.0.0",
  "name" : "AdverseEventCRSerCrit",
  "title" : "Adverse Event Clinical Research Seriousness Criteria",
  "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" : "Action criteria usually associated with serious events that pose a threat to a patient's life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). 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" : "Results In Death"
          },
          {
            "code" : "C84266",
            "display" : "Is Life Threatening"
          },
          {
            "code" : "C83052",
            "display" : "Requires Inpatient Hospitalization"
          },
          {
            "code" : "C11338",
            "display" : "Results In Persistent Or Significant Disability"
          },
          {
            "code" : "C83117",
            "display" : "Congenital Anomaly or Birth Defect"
          },
          {
            "code" : "C82521",
            "display" : "Other Medically Important Condition"
          },
          {
            "code" : "C201939",
            "display" : "Required Intervention to Prevent Permanent Impairment/damage"
          }
        ]
      }
    ]
  }
}

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