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. The presentation will also include a discussion of FDA expectations, reporting requirements, and University of Pittsburgh O3IS guidance for the management of external sites.
Speaker: Cynthia Kern, Director, Office for Investigator-Sponsored IND and IDE Support
No registration required. Submit advance questions or comments to firstname.lastname@example.org.
Friday, January 18 at 9:00 a.m. to 10:00 a.m.