Investigator - Sponsored IND and IDE Support

Forms, Forms, Forms! Overview and Update of Commonly Used FDA Forms


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

This presentation will include an overview and discussion of commonly used FDA forms in the submission of Investigational New Drug applications and subsequent FDA correspondence. Forms to be discussed will include 1571, 1572, 3500a, 3674 and 3926.

Click here to register for the program. Submit advance questions or comments to o3is@pitt.edu.

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.