ICH E2A Clinical safety data management: definitions and standards for expedited reporting

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/377/95
Effective from01/06/1995
KeywordsClinical development, clinical safety reporting, expedited reports, adverse drug reaction (ADR)
DescriptionThis 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.

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