Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 4: Clinical Trial Contracts (2019)


Topics

  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



Acknowledgement

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


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.