(FALL 2009)

A required course in the Certificate Program in Clinical Trials: Medical Device and Drug Development, and an elective course in the Certificate Program in Medical Product Development.
Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies. CRAs, CRCs, clinical program managers, and clinical trial investigators with two years experience in clinical trials may substitute this course with a three-unit elective. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 30 contact hours.

Nancy A. Schwartz, M.B.A., RN, is a medical industry consultant for SearchLight Consulting. Her 12 years of experience in clinical research has been focused on specialized projects and programs dealing with regulatory and product liability issues. The therapeutic areas she has been involved with include cardiology, obstetrics/gynecology, and oncology. Schwartz has also consulted on all aspects of clinical coordination, monitoring, and managing clinical studies. She is a guest lecturer on these topics at the USC School of Pharmacy.