Audit Preparedness
FDA/EMA Inspection
The YCCI resources and support are designed to help support and reduce the regulatory and reporting burden on investigators and teams before, during, and after inspections. If you have been notified of the potential of an inspection by a research sponsor or given notice of a pending inspection by Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory agencies notify the YCCI immediately.
For more information on training, visit the YCCI Workforce Development & Education page.
Audit Preparedness Contact
Nancy S. Shelton, M.B.E.C., CCRP, CHRC, Senior Associate Director, Clinical Research Quality Assurance and Research Regulatory Initiatives