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

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