Cooper Lane
Stanford, CA 94305
USA
The Stanford Center for Clinical Research and Spectrum present:
Successful Clinical Trial Monitoring
This course will cover the essential elements of monitoring clinical trials and the interactions between the sponsor and study site(s) during clinical investigation. Learn more about this important topic and be prepared for your next monitoring visit!
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Course Objectives:
1) Review tasks to be completed before, during and after a monitoring visit
2) Examine compliance audits, fraud and misconduct
3) Evaluate importance of accurate data entry and product accountability
Speaker:
Savita O. Sinha, M.S, SOS Clinical Consulting, Instructor – UCSC Extension
Abstract:
This talk presents 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.
RSVP:
Registration is done through STARS. https://axess.sahr.stanford.edu/group/guest/search-catalog. Learners can search for “clinical trial monitoring” and the class description and “enroll” button become available. Thanks!