E2A: Clinical Safety Data Management : Definitions and Standards for Expedited Reporting

Regulatory Resource: E2A: Clinical Safety Data Management : Definitions and Standards for Expedited Reporting

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

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