A major trend among life science organizations has been the recent shift from manual, paper-based clinical data collection processes to the predominant use of electronic systems that expedite the availability of accurate clinical trial data. This course examines some of the key issues surrounding the industry's adoption of Electronic Data Capture (EDC) and gives students the opportunity to use EDC software on classroom computers during simulated clinical trials. The instructor illustrates the major differences between EDC software and paper-based trials, and systematically examines the costs, risks, related process changes and other business and regulatory implications of this shift. A significant portion of classroom time is devoted to hands-on EDC activities using actual commercial EDC systems from industry-leading vendors. Students will take on the roles of study coordinators, investigators, study monitors, data managers, and other sponsor personnel, using those commercial EDC systems to explore key EDC concepts and tasks performed during clinical trial startup, conduct, and closeout.
The course benefits clinical site personnel (primarily study coordinators and investigators) as well as bioscience industry professionals having roles in data management, study monitoring, clinical management, and others involved in the evaluation, design, and implementation of an EDC system.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.