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ValueSet: Adverse Event Clinical Research Outcomes

Official URL: http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes				Version: 1.0.0	Highlight text changes?
			Maturity Level: 1	Responsible: Health Level Seven International	Computable Name: AdverseEventClinicalResearchOutcomes
Other Identifiers: OID:2.16.840.1.113883.11.21025
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

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.

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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Description of the above table(s).