This course introduces the international standards for ethical conduct of research and maintaining the highest level of scientific quality when conducting clinical trials. Topics include the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials; the phases of clinical trials leading up to FDA approval of a new drug or device; and how to get a trial up and running including the selection of qualified investigators, obtaining approval to conduct the study from an ethics committee, and completing the regulatory documentation that is required for getting a site ready to enroll patients. The course also covers ensuring data integrity, handling ethical dilemmas, and reporting of serious adverse events. Case studies, review of current media, and exercises will be used to practice the application of information provided in class and to demonstrate GCP compliance from an industry perspective. Group discussions, individual and group projects, and guest speakers help students learn the practical skills used in the field.

Note that this information may change at any time. Please visit the Student Link for the most up-to-date course information.