Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide: backwards and forwards compatibility

Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide: backwards and forwards compatibility

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Language(s):
English
Format:
Text
Subject(s):
Clinical Coding
Databases, Pharmaceutical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Electronic Transmission of Individual Case Safety Reports (ICSRs)’. This Appendix is intended to assist reporters and recipients (including pharmaceutical companies, authorities and non-commercial sponsors) in implementing systems with special focus on the recommendations for conversion back and forth between the previous standard, i.e., E2B(R2) and this standard, i.e., E2B(R3). The evolution of the guideline, from E2B(R2) to E2B(R3), has the consequence that ICSRs cannot be perfectly converted from one standard version to the other (either backwards or forwards). Repeated conversion could result in transformation or loss of information. Therefore receivers need to evaluate contents carefully. This document presents the recommendations for conversion agreed within ICH so as to provide a reference to system providers, and a common understanding on the way to convert ICSRs and ICSR acknowledgments (ICSR ACKs) between E2B(R2) and E2B(R3).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (60 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918469488306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918469488306676