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NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS

NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS. Justine Gordon – Moderator Research Foundation for The State University of New York Leigh Gentilcore Stony Brook University Mont Brownlee JHMI Clinical Trials Office. Objectives.

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NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS

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  1. NEGOTIATING AND IMPLEMENTINGMASTER CLINICAL TRIAL AGREEMENTS Justine Gordon – Moderator Research Foundation for The State University of New York Leigh Gentilcore Stony Brook University Mont Brownlee JHMI Clinical Trials Office

  2. Objectives • Learn how to identify when and what type of Master Clinical Trial Agreement is appropriate • Understand who needs to be brought into the discussion • Discover the biggest obstacles to the negotiations and how these can be managed or overcome

  3. What is aMaster Clinical Trial Agreement • An agreement which articulates agreed-upon terms and conditions between a university and a sponsor, which can then be used as a basis for future projects with that sponsor

  4. Types of MCTAs • Investigator-Initiated Study (IIS) • Sponsor-Initiated

  5. Who Initiates • Sent from industry to institution • Go out blind to initiate MCTAs

  6. Typical Provisions • Intellectual Property • Publication • Indemnification • Confidentiality • Subject Injury

  7. Multiple MCTAs with the Same Company? • Both IIS and Sponsor-initiated • MCTA by phase

  8. Clinical Research Organizations • How do CROs fit into the picture?

  9. Alternatives to MCTAs • Model/Template Agreement

  10. Regulatory Considerations • Magi • Pharma Guidelines

  11. Case Studies • Case Studies • Special Circumstances • Mergers/Buyouts/Transitions

  12. Resources

  13. Questions?

  14. Contact US • Leigh Gentilcore, MBA • Clinical Trials Administrator • Office of Sponsored Programs • W5510 Melville Library • Stony Brook, NY 11794-3362 • 631-632-4949 • Leigh.Gentilcore@stonybrook.edu • Mont Brownlee, III, J.D. • Associate Director, Contracting • Office of Research Administration • The Johns Hopkins School of Medicine • 1629 Thames St, Suite 200, Baltimore MD 21231 • 410-502-0232 • fbrownl1@jhmi.edu • Justine Gordon, CRA • Associate Director • Grants & Contracts Administration • The Research Foundation for SUNY • 35 State Street • Albany, NY 12207 • 518-434-7105 • justine.gordon@rfsuny.org

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