Investigator-Sponsored Multicenter Research Conducted under an IND or IDE

January 10, 2018 - 11:00am to 12:00pm

Cynthia Kern, Director, Office for Investigator-Sponsored IND and IDE

This presentation will provide an overview of investigator-sponsored clinical trials with multiple research sites.  Specifically, we will address the oversight responsibilities for multicenter clinical trials in regard to monitoring, risk management, data collection and compliance.  This will also include a discussion of the FDA expectations and reporting requirements and University of Pittsburgh O3IS guidance for the management of external sites.

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Location and Address

RCCO Learning Resource Center, Room 305
Hieber Building, 3500 Fifth Avenue