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Tag Archive: Investigator Brochures
Seriousness, Expectedness and Investigator Brochures
There is some confusion that I have observed in how Serious Adverse Events (SAEs), Adverse Events (AEs) and expectedness are handled in Investigator Brochures (IBs). First a quick review of the concept of the IB. The basic requirements are described in ICH E6 which is used in most countries now.[…]
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