'Sensitivity to Clinical Research Fraud and Misconduct'

Gain a better understanding and sensitivity of Clinical Research Fraud and Misconduct and how it impacts the primary objectives of protecting Research Subjects and Consumers, and ensuring the integrity of Clinical Investigations and Products. This training modules will focus on the:

1. Introduction to Fraud, Misconduct, and Noncompliance
2. In-depth classification of Fraud and Misconduct
3. Regulations governing repeated or deliberate Noncompliance
4. Consequences of Fraud and Misconduct
5. Understanding how severe Noncompliance occurs
6. Elements to Prove and the Burden of Proof
7. Umbrella of Protection to prevent Fraud and Misconduct
8. Responsibilities of Sponsors, CROs, IRBs, and Investigators
9. Difference between Noncompliance, Misconduct and Fraud
10. FDA and Office of Criminal Investigation Process for Handling
11. Who is usually blamed for and involved in Fraud and Misconduct
12. Legal, Regulatory, FDA and ICH definitions of Fraud and Misconduct
13. Complaint and Whistleblower Process and Laws, Including False Claims

1 1/2 hours of Education for the entire Research Community including Monitors, Auditors, Coordinators, and Investigators.
1.5 Contact Hours or 0.2 CEUs
$75.00