 | | | Sponsored by The Northwestern University's Feinberg School of Medicine and the Northwestern University Clinical and Translational Sciences (NUCATS) Institute in collaboration with the Association of Clinical Research Professionals (ACRP). George Turnbull is a Clinical Trials Analyst in the Center for Clinical Trials in the University of Maryland, School of Medicine. He is responsible for developing the internal budget in collaboration with the study team, and negotiating the budget with the sponsor. He is also responsible for developing a billing plan in conjunction with the budget to ensure billing compliance. Prior to joining the Center for Clinical Trials, he was the Compliance Administrator for the University of Maryland, College Park, where he supported the Institutional Review Board, the Institutional Animal Care and Use Committee, the Conflict of Interest Committee, and export control. He received his BA from the University of Maryland, College Park, and his JD from the University of Baltimore. Negotiating the Clinical Trial Budget presented by George Turnbull, JD, Center for Clinical Trials, University of Maryland School of Medicine The sponsor and the research site typically develop their budgets from differing points of view. Sponsors are often oriented towards defining costs on a per-patient basis, with concern for allocating the risks associated with recruitment to the institution conducting the trial. Institutions are typically concerned with ensuring that the basic elements of cost such as administrative fees and start-up costs are covered independently of the risks associated with attaining the target enrollment. Agreement can often only be reached by ensuring that one element of cost will be sufficient to cover another, and that the associated risk of attaining it will be sufficiently identified and controlled to protect viability of the trial. The presentation will address some of the means by which this can be accomplished.
1. Assess the integrity of the budget developed by the site
2. Assess the budget offered by the sponsor
3. Resolve the differences to negotiate the agreement
For more information on this event to to be included on our mailing list for future activities, please email us at nucats-ed@northwestern.edu. For questions during the conference on Friday, May 16, 2008, please call 312-926-2383.
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