Application of Good Clinical Practices

This course will explore the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Students will have the opportunity to enhance their knowledge of topics including: the definition of GCPs; the effect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research environment; and compliance and accountability during a clinical trial. Students will also learn about the basic elements of the clinical data management process.