Clinical Trials Office

临床试验办公室

• 批准号: 8038255
• 负责人: YELENA NOVIK
• 金额: $ 17.43万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8038255
• 关键词: Appointment; Budgets; Cancer Center; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Conduct Clinical Trials; Critiques; Data; Data Analyses; Data Collection; Development; Discipline of Nursing; Ensure; Environment; Funding Agency; Goals; Growth; Guidelines; Institutes; Institution; Malignant Neoplasms; Medical; Medical center; Meta-Analysis; Modeling; Outcome; Procedures; Process; Protocols documentation; Quality Control; Reporting; Research; Research Ethics Committees; Research Personnel; Resources; Services; Therapy Clinical Trials; Time; Translating; anticancer research; data management; improved; interdisciplinary collaboration; medical schools; meetings; novel; programs; protocol development; quality assurance; response; success

The Clinical Trials Office (CTO) provides administrative, research and educational services to the Cancer Institute investigators and research staff conducting clinical trials. It serves as the main coordinating center for cancer-related clinical trials from concept development and submission to closure including protocol development, regulatory and compliance guidance, administrative submissions, data collection and data management, data analysis, and quality control functions, and serves as the administrative interface to other clinical research organizations at the NYU Medical Center. The goals of this resource are to: Facilitate clinical trials by providing a framework for development, submission, and conduct of clinical trials. Enhance and facilitate data collection and reporting of clinical cancer research data. Provide educational programs for the CTO staff and clinical investigators. Promote interdisciplinary collaboration and a venue for translating research findings to the clinical arena In response to the previous critique, internal audits, and the review of external consultants, significant changes have occurred within the CTO since the last review. These changes include the appointment of new medical and administrative directors, new standard operating procedures, and restructuring of data management. These improvements have produced a CTO that better meets the needs of investigators performs more effectively within the NYU School of Medicine clinical research environment. Currently, the CTO supervises 49 research staff and manages 158 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）为癌症研究中心提供行政、研究和教育服务。 进行临床试验的研究机构研究人员和研究人员。它作为主要的协调中心 癌症相关临床试验从概念开发、提交到结束，包括方案 制定、监管和合规指南、行政申报、数据收集和数据 管理，数据分析和质量控制功能，并作为其他管理界面 纽约大学医学中心的临床研究组织。该资源的目标是： 通过为临床试验的开发、提交和实施提供框架，促进临床试验。 加强和促进临床癌症研究数据的收集和报告。 为CTO员工和临床研究者提供教育计划。 促进跨学科合作，并为将研究成果转化为临床竞技场提供场所 针对先前的批评、内部审计和外部顾问的审查， 自上次审查以来，CTO内部发生了变化。这些变化包括任命 新的医疗和行政主任，新的标准操作程序，以及数据重组 管理这些改进产生了一个更好地满足调查人员需求的CTO 在纽约大学医学院的临床研究环境中表现得更有效。目前 CTO监督49名研究人员，管理158个开放协议。首席技术官继续扩大， 完善其功能，作为临床研究企业的中央协调中心， 纽约大学CI。