Investigator-Sponsored Multicenter Research Conducted under an IND or IDE

December 7, 2017 -
11:00am to 12:00pm

Speaker: Cynthia Kern, Director, Officer of Investigator-Sponsored IND and IDE Support

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.

Click here to register for program as seating is limited. Submit advance questions or comments to o3is@pitt.edu.

Location and Address

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