ICH E2A CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
Title:
ICH E2A CLINICAL SAFETY DATA MANAGEMENT:
DEFINITIONS AND STANDARDS FOR
EXPEDITED REPORTING
Origin/Publisher:
ICH
Content:
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.