adverse-event-clinical-research-seriousness-criteria
type: ValueSet
node role: treeRoot
id:
  v: adverse-event-clinical-research-seriousness-criteria
meta:
  profile:
    v: http://hl7.org/fhir/StructureDefinition/shareablevalueset
    link: http://hl7.org/fhir/StructureDefinition/shareablevalueset
text:
  status:
    v: generated
  div: Generated Narrative: ValueSet adverse-event-clinical-research-seriousness-criteria Profile: Shareable ValueSet Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl Code Display C48275 Results In Death C84266 Is Life Threatening C83052 Requires Inpatient Hospitalization C11338 Results In Persistent Or Significant Disability C83117 Congenital Anomaly or Birth Defect C82521 Other Medically Important Condition C201939 Required Intervention to Prevent Permanent Impairment/damage
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
  value: code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
  value: integer
    v: 1
url:
  v: http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria
identifier:
  system:
    v: urn:ietf:rfc:3986
  value:
    v: urn:oid:2.16.840.1.113883.11.21026
version:
  v: 1.0.0
name:
  v: AdverseEventCRSerCrit
title:
  v: Adverse Event Clinical Research Seriousness Criteria
status:
  v: active
experimental:
  v: false
date:
  v: 2023-07-28T19:27:19+00:00
publisher:
  v: Health Level Seven International
contact:
  telecom:
    system:
      v: url
    value:
      v: http://hl7.org
  telecom:
    system:
      v: email
description:
  v: 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:
  v: 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:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    concept:
      code:
        v: C48275
      display:
        v: Results In Death
    concept:
      code:
        v: C84266
      display:
        v: Is Life Threatening
    concept:
      code:
        v: C83052
      display:
        v: Requires Inpatient Hospitalization
    concept:
      code:
        v: C11338
      display:
        v: Results In Persistent Or Significant Disability
    concept:
      code:
        v: C83117
      display:
        v: Congenital Anomaly or Birth Defect
    concept:
      code:
        v: C82521
      display:
        v: Other Medically Important Condition
    concept:
      code:
        v: C201939
      display:
        v: Required Intervention to Prevent Permanent Impairment/damage