UCSC Ext. in Silicon Valley, Clinical Trials Site Monitoring I, Jan. 22 – Feb. 12, 2010 Course Description: This course 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, initiation visits, source documentation, regulatory documentation, and adverse event reporting. The use of tracking tools for compliance, screened and valid patients, product accountability and medical record review are also covered. Instructor: Patty Kasper, MS Dates and Times: Fri 2:00PM to 6:00PM Jan 22, 2010 Sat 9:00AM to 5:00PM Jan 30, 2010 to Feb 06, 2010 Fri 2:00PM to 6:00PM Feb 12, 2010 Number of Sessions: 4 Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara Tuition: $645 (Early Enrollment - $580.50)
