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 course covers expectations of the FDA, the sponsor, and the site. The process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting are additional topics covered. Included in the course are the process of medical record review and maintenance, case report form completion, product accountability, and various tasks associated with different monitoring visits.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.