This course introduces the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed for the clinical trial professional on procedures for ensuring GCP compliance from an industry perspective. Topics include identifying and selecting qualified investigators, obtaining ethical approval to enroll patients, and initiating sites successfully. The course also covers issues related to collecting required regulatory documentation, verifying high quality data, maintaining study materials accountability, and reporting serious adverse events. Group discussions and guest speakers help students learn the practical skills used in the field.