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

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: ICH guideline E2B (R3) - Step 5 - questions and answers

Keywords: Transmission 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

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements ...

Adopted Reference Number: CHMP/ICH/287/1995 Legal effective date: 01/07/2013