ICH E2A Clinical safety data management: definitions and standards for expedited reporting
| Current effective version |
|
| 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. |
