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Who Owns the Protocol?

Apr 30, 2011 4:15pm ‐ Apr 30, 2011 5:15pm

Credits: None available.


Physician disaffiliation from private practice to employment by hospital corporations is a growing trend that impacts the research process. The contract becomes your guide to mitigate dispute over ""ownership"" of the protocol. How do you confront the logistics of sponsor demands, IRB requests, hospital politics, and coordinator loyalty while maintaining patient safety? What are the ramifications of having a loss of income? How do you amend clinical trial agreement? How do you navigate the legalities of conflict while active litigation is in process?

  • Describe the legal ramifications of breach of contractual duties.
  • Identify the steps necessary to maintain the conduct of the protocol while transitioning the protocol to another site and/or PI.
  • Identify contract wording necessary to prevent dispute of ownership in the event of the loss of the PI and all sub-investigators.


  • Kathleen Mostek, RN, CCRC, Director of Research, MCVI and MidMichigan Medical Center


Credits: None available.

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