Clinical Trials Site Monitoring I

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.


Prerequisites :

Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X404.(4) 5/4/2019 09:00 AM SANTA CLARA $750 Savita O. Sinha Enroll