Clinical Trials Site Monitoring

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 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.

Learning Outcomes

At the conclusion of the course, you should be able to

• Explain the regulatory requirements of monitoring a clinical study site.
• Explain the roles and responsibilities of sponsors, CROs, and study sites during monitoring visits.
• Plan and execute monitoring visits before, during, and after site visits.
• Complete monitoring visit reports.
• Track key issues involved in monitoring a clinical study site, including source data verification, data integrity, and TMF/ISF inspection readiness.

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.

*This course may be applied to a certificate only if you are currently declared in a program.