CLINICAL TRIALS OFFICE

临床试验办公室(CTO)为纽约大学癌症研究所(NYUCI)的研究人员提供临床、转化性和基于人群的研究的行政和教育支持。它还为研究人员提供了实现研究目标的基础。它是议定书制定、监管和合规指导、行政提交、数据收集和管理、数据分析和质量保证的主要协调中心。它也是纽约大学朗格尼医学中心(NYULMC)其他临床研究组织的管理界面。该资源的目标是：通过提供临床试验开发、提交机构批准(PRMS和IRB)、预算和进行临床试验的框架，促进临床试验；通过维护数据管理、监管和护理指南以及试验审计，确保整个机构和战略联盟中临床试验行为的适当标准；为CTO工作人员、研究员和临床研究人员提供教育计划和指导；促进跨学科合作和将研究结果转化为临床领域的场所。自上次审查以来，任命了一名新的医务主任，设立了一些高级职位，随后填补了这些职位。这导致精简程序和制定新的衡量标准，以更好地评估资源分配情况。自上次审查以来，主要机构和贝尔维尤医院中心的应计费用有所增加。目前，CTO管理着49名研究人员，管理着151个开放协议。CTO继续扩大和完善其职能，作为纽约大学临床研究企业的中央协调中心。

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.