Contact Us

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, Liaison, CTSI Office of Regulatory Affairs

  •, 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