HL7 Terminology (THO)
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HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 6.0.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

ValueSet: Adverse Event Clinical Research Seriousness Criteria

Official URL: http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria Version: 1.0.0
Active as of 2023-07-28 Maturity Level: 1 Responsible: Health Level Seven International Computable Name: AdverseEventCRSerCrit
Other Identifiers: OID:2.16.840.1.113883.11.21026

Copyright/Legal: 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

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

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

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

 

Expansion

Generated Narrative: ValueSet

This value set contains 7 concepts

CodeSystemDisplay
  C48275http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlDeath Related to Adverse Event
  C84266http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlIs Life Threatening
  C83052http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlRequires Inpatient Hospitalization
  C11338http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlResults In Persistent Or Significant Disability
  C83117http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlCongenital Anomaly or Birth Defect
  C82521http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlOther Medically Important Condition
  C201939http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlRequired Intervention to Prevent Permanent Impairment/damage

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code

History

DateActionAuthorCustodianComment
2024-03-02createBret HealeBRRAdverseEvent Clinical Research value sets; up-485