Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 6: Liability and Indemnification (2019)


  1. Common Purpose, but Competing Perspectives
  2. Who? How Involved?
  3. When Should you Consider Transferring Risk?
  4. Are there Benefits to Transferring Risk?
  5. The Contract: A Risk Transfer Tool
  6. Start by… Identifying Potential Risks
  7. What is Indemnification?
  8. Considerations for Contractual Indemnity
  9. Think carefully before contractually agreeing to indemnity…
  10. Example: Sponsor Indemnification
  11. Conditions of Indemnification by Sponsor
  12. If the Other Party Cannot Indemnify?
  13. Research – Related Injury/ Illness
  14. Indemnification & Subject Injury
    1. Study Subject Injury Example - #1
    2. Study Subject Injury Example - #2
  15. Indemnification & Subject Injury
  16. Insurance Terms
  17. Common Problems with Insurance Terms in Contracts
  18. What if Injury Caused by Person Not a Signatory to the Clinical Trial Application (CTA)?
  19. Harmonizing Indemnity & Insurance Terms
  20. Working with Insurance – Keep Good Written Records

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.