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.