Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 4: Clinical Trial Contracts (2019)

1. Learning Objectives
2. Elements of a Sponsored Research Agreement
3. Confidential Information
4. Patient Privacy/ Use of Protected Health Information (PHI)
5. Publication
6. Protection of Inventions/ Indemnification/ Subject Injury
7. Compliance with Contract Terms Impacting Study Conduct
   1. Case Report Form (CRF) Reporting
   2. Principle Investigator Change
   3. Adverse Event Reporting
   4. Monitoring
   5. Record Storage
8. Budgeting Terms: Medicare Secondary Payor Act
9. Budgeting Terms: Anti-Kickback
   1. Federal Anti-Kickback Laws (Stark Law)
10. Budgeting Terms: Referral Payments
11. Budgeting Terms: False Claims Act

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu