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).

Credit Hours

3

Lecture Hours

3

Corequisite

CRC101 Introduction to Clinical Research Minimum Grade of: C

Attributes

• Free Elective

Program Major Restrictions

Clinical Research Coordin Cert