Investigator - Sponsored IND and IDE Support

Investigator-Sponsored Multicenter Research Conducted under an IND or IDE


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.

Investigator-Sponsored Multicenter Research Conducted under an IND or IDE

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.

Investigator-Sponsored Multicenter Research Conducted under an IND or IDE

Speaker: Cynthia Kern, Director, O3IS

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.