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Implications of FDA Risk Based Approach Trailer

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Uploaded by on Oct 21, 2011

The FDA's Guideline for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring, and most recently the agency released a draft guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, we will discuss the content and the implications to sponsor monitoring and clinical investigation sites.

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