ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide

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Current effective version

Revision 3 - Adopted guideline

Reference numberCHMP/ICH/287/1995
Effective from28/07/2013
KeywordsTransmission identification, batch wrapper, message wrapper, case safety report, primary source, sender, literature reference, study identification, patient characteristics, parent-child/foetus report, reaction, event, results of tests, drug information, acknowledgement message

This document provides guidance on the implementation of the standard adopted by the ICH for electronic transmission of individual case safety reports (ICSRs). Read together with:


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