CRC102 Clinical Research Regulatory Compliance
Introduction to the Food and Drug Administration (FDA) regulatory process and regulatory requirements for clinical research. Includes an overview of the role and function of the FDA, the drug development process, preparation and maintenance of an Investigational New Drug (IND), regulatory documentation, safety reporting, and Good Clinical Practices (GCPs).
Corequisite
CRC101 Introduction to Clinical Research Minimum Grade of: C
Program Major Restrictions
Clinical Research Coor Adv Ct