ICH E2A Clinical safety data management: definitions and standards for expedited reporting - Scientific guideline

This document aims to develop standard definitions and terminology for key aspects of clinical safety reporting. I also provides guidance on the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e. pre-approval) phase.

Keywords: Clinical development, clinical safety reporting, expedited reports, adverse drug reaction (ADR)

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step...

AdoptedReference Number: CPMP/ICH/377/95Legal effective date: 01/06/1995