1 / 14

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.

mardi
Download Presentation

NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related