CLINICAL TRIALS OFFICE

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The Clinical Trials Office (CTO) provides administrative and educational support for clinical, translational and population based studies for investigators of the NYU Cancer Institute (NYUCI). It also provides the research staff to carry out the objectives of the study. It serves as the main coordinating center for protocol development, regulatory and compliance guidance, administrative submissions, data collection and management, data analysis, and quality assurance. It also serves as the administrative interface to other clinical research organizations at the NYU Langone Medical Center (NYULMC). The goals of this resource are to: facilitate clinical trials by providing a framework for trial development, submission for institutional approval (PRMS and IRB), budgeting and conduct of clinical trials; ensure appropriate standards of clinical trial conduct across the institution and strategic alliances by maintaining data management, regulatory, and nursing guidelines as well as auditing conduct of trials; provide educational programs and mentorship for the CTO staff, fellows, and clinical investigators; and promote interdisciplinary collaboration and venues for translating research findings to the clinical arena. Since the last review, a new medical director was appointed and a number of senior level positions were established and subsequently filled. This resulted in streamlining processes and the development of new metrics to better assess resource allocations. Since the last review accruals increased at the main institution and at Bellevue Hospital Center. Currently, the CTO supervises 49 research staff and manages 151 open protocols. The CTO continues to expand and improve its function to serve as the central coordinating center for the clinical research enterprise at the NYUCI.