November 9, 2018

@LKSC 308, 8:30-12:30pm: “Successful Clinical Trial Monitoring.” Savita O. Sinha, M.Sc, SOS Clinical Consulting, Instructor, UCSC Extension, has worked as a clinical research consultant for the past 20 years, managing multi-center, global phase II, phase III and post-marking studies.  She will present the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The expectations of the FDA, the sponsor and the site are covered. Participants are exposed to the process of site selection, budgeting, completion of regulatory documents, adverse event reporting, and tasks to be performed before, during and after a monitoring visit. Risk based monitoring; regulatory obligations; compliance audits; fraud and misconduct; and the importance of accurate data entry and product accountability for compliance are also covered.  STARS Course Code SCCR-5062