Contact Us

Terra Hughes, M.S., Director, CTSI Office of Regulatory Affairs 

• Scientific Review Committee
• Data and Safety Monitoring Board
• Training and Lectures
• General Questions

Uma Ganapati, Ph.D., Associate Director, CTSI Office of Regulatory Affairs

• Internal Auditing and Monitoring
• FDA and Sponsor Inspection/Audit Preparation
• Regulatory Binder Preparation

Elaine Cooperstein, MS, CCRP, ClinicalTrials.gov Liaison, CTSI Office of Regulatory Affairs

• ClinicalTrials.gov, including PRS account access, registration, and resulting reporting

Marlene Berro, MS, RAC, Director, FDA Affairs

• FDA IND/IDE Guidance 
• ResearchGo Site

 

Required forms for submission to DSMB to be submitted to the Office of Regulatory Affairs.

1. CTSI Serious Adverse Event Reporting Form
2. Single Subject Exception Request Form