ICH E2A Clinical safety data management: definitions and standards for expedited reporting - Scientific guideline
Table of contents
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)
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... (PDF/177.91 KB)Adopted
First published: 01/06/1995
Last updated: 01/06/1995
Legal effective date: 01/06/1995