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ICH GCP Guidelines Overview for CDM by aks_p is a document available to read on EtoBox.

What is ICH GCP Guidelines Overview for CDM about?

This document discusses important ICH guidelines related to clinical data management (CDM). It identifies five key guidelines: E2A, E3, E6, E8, and E9. E2A defines important safety terms like adverse events, serious adverse events, adverse drug reactions, and unexpected adverse drug reactions. It also specifies timeframes for safety reporting. E3 provides guidance on the content and structure of clinical study reports, including standard table formats. E6 is the consolidated Good Clinical Practice guideli

Author

aks_p

Language

EN