4 Focuses on the overall management of Phase I, II, and III clinical trials in industry, academia, and government settings.
Emphasis is placed on development, initiation, and execution of clinical trials.
Course content includes intensive training in the processes involved in site evaluation and selection, preparation for investigator meetings, site initiation, site management, clinical research monitoring, auditing and compliance practices, clinical research management tracking and reporting systems, adverse event reporting, data safety review boards, data management, site termination, and clinical trial material.