ICH E2A Clinical safety data management: definitions and standards for expedited reporting
Current effective version |
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Reference number | CPMP/ICH/377/95 |
Published | 01/06/1995 |
Effective from | 01/06/1995 |
Keywords | Clinical development, clinical safety reporting, expedited reports, adverse drug reaction (ADR) |
Description | 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. |