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 |

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