The newly established Office of Sponsor and Regulatory Oversight (OSRO) ensures CCRs regulatory compliance with sponsor obligations for Investigational New Drugs (IND) and Investigational Device Exemptions (IDE), a critically important role for the CCR clinical research program and its investigators. In addition, this office provides analytic support, leads the pharmacovigilance program, monitors clinical trials, and serves as the subject matter experts regarding FDA regulations.
Contact Information:
Shy Shorer, Medical Director
9609 Medical Center Drive, Room 2W332
240-276-5096
shy.shorer@nih.gov