Common issues and concerns associated with drug safety surveillance within clinical trials are the focus of this course. Topics include the defining and identifying of adverse experiences, verifying drug safety, regulations regarding surveillance of investigational and marketed products, safety reporting requirements, analyzing study results to determine safety, and required actions in the event of safety issues. Useful from both site and sponsor perspectives.
Other Credits: BRN: 16 CE hours.
Note: Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40206
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management