CLINICAL TRIALS OFFICE

临床试验办公室

• 批准号: 8436453
• 负责人: William L. Carroll
• 金额: $ 13.45万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8436453
• 关键词: Budgets; Cancer Center Support Grant; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Conduct Clinical Trials; Coupled; Data; Data Analyses; Data Collection; Data Reporting; Development; Discipline of Nursing; Disease Management; Education; Educational Curriculum; Ensure; Fellowship; Goals; Growth; Guidelines; Hematology; Hospitals; Institutes; Institution; Institutional Review Boards; Instruction; Kaplan Cancer Center; Malignant Neoplasms; Medical Oncology; Medical center; Mentors; Mentorship; Metric; Modeling; Monitor; Outcome; Physician Executives; Positioning Attribute; Process; Protocols documentation; Research; Research Infrastructure; Research Personnel; Resource Allocation; Resources; Safety; Services; Structure; System; Therapeutic Agents; Translating; Work; anticancer research; bench to bedside; data management; improved; interdisciplinary collaboration; novel therapeutics; operation; patient population; population based; programs; protocol development; quality assurance; success

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.

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机会。它是协议开发、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。它还充当纽约大学朗格尼医学中心 (NYULMC) 的其他临床研究组织的管理界面。该资源的目标是： 通过提供试验开发框架、提交机构批准（PRMS 和 IRB）、预算编制和临床试验实施来促进临床试验；通过维护数据管理、监管和护理指南以及审计试验行为，确保整个机构和战略联盟的临床试验行为符合适当的标准；为 CTO 员工、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成果转化为临床领域的场所。自上次审查以来，任命了一位新的医疗主任，并设立并随后填补了一些高级职位。这导致了流程的简化和新指标的开发，以更好地评估资源分配。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 监管 49 名研究人员并管理 151 个开放协议。 CTO 不断扩大和完善其职能，作为 NYUCI 临床研究企业的中央协调中心。