CLRE 6730 - Ensuring Compliance and Detecting Fraud and Misconduct in Clinical Trials

Prerequisite: CLRE 6100. This course provides the student with an overview of Good Clinical Practice and regulatory inspections and their role in ensuring compliance in the development of drugs, biologics, and devices. The details and consequences of fraud and misconduct are illustrated in the context of case studies and regulatory agency warning letters. 3 credits.