May 07, 2024  
2020-2021 College Catalog 
    
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2020-2021 College Catalog [ARCHIVED CATALOG]

CRC 201 - Clinical Research Regulatory Compliance

3 Credits, 3 Contact Hours (3 lec.)

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).

Recommendation: Completion or concurrent enrollment in CRC 101 . If any recommended course is taken, see a financial aid or Veteran’s Affairs advisor to determine funding eligibility as appropriate.