Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials 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

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