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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: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn: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

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)

 

Expansion

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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