The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification

Issue Date: February 27, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final

The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification

This document is a guide for implementing the standard adopted by the ICH1 for electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2 Expert Working Groups (EWGs). The E2B(R3) EWG provided business requirements and the M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the ICH E2B(R3) EWG in November 2010.

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