ICH has published Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Module III for ICH Guideline E2B (R3), the third of three planned guidelines concerning Clinical Safety Data Management, planned by the E2B (R3) Expert & Implementation Working Group.
The new training module introduces the technical and practical implementation of the ICH E2B (R3) Guideline specifications for electronic submission of ICSRs.
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