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中文摘要
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临床研究支持办公室 (CISC) 是一个由具有以下能力的个人组成的集中组织: 特定和专门的角色以及提供必要支持的协议和数据管理系统 在南加州大学/诺里斯综合癌症中心进行研究试验。这种集中管理 临床研究活动对于在不同临床地点有效进行临床试验至关重要 癌症中心。 CISC 为癌症中心的临床研究人员提供服务和技术 和科学咨询,以促进互动并提高科学生产力。 CISO 提供了 方案开发、审查、监管合规、研究实施和管理的集中管理 监控和质量保证。这种共享资源有两个组成部分: 集中式协议 行政部门和研究护理/数据管理部门。礼宾管理单位 提供进行外部资助和内部同行评审所需的集中支持服务 并监测研究临床试验。研究护理/数据管理单位提供 在患者资格评估、数据质量方面为研究人员提供建议和协助的集中职能 控制和监督。癌症中心在7楼提供了一套办公室。 由于临床研究的发展,Topping Tower 和其他员工办公室分布在医院各处。 卫星办公室位于洛杉矶县南加州大学的患者护理区附近 医疗中心。 CISO 与生物统计核心具有重要的职能互动和协调 资源、癌症研究信息学核心 (CRIC) 以及方案审查和监测系统 (临床研究和质量保证委员会)提供科学的同行评审和质量 中心临床试验的保证监控。
英文摘要
The Clinical Investigations Support Office (CISC) is a centralized organization of individuals with specific and specialized roles and a protocol and data management system that provides essential support for investigational trials at the USC/Norris Comprehensive Cancer Center. This centralized administration of clinical research activities is critical to the efficient conduct of clinical trials at the various clinical sites of the Cancer Center. CISC provides the Cancer Center's clinical investigators access to services, technologies and scientific consultation to foster interaction and enhance scientific productivity. CISO provides a centralized administration for protocol development, review, regulatory compliance, study conduct and monitoring, and quality assurance. This shared resource has two components: a centralized Protocol Administration Unit and a Research Nursing/Data Management Unit. The Protocol Administration Unit provides the centralized support services necessary for the conduct of externally-funded and internally peerreviewed and monitored research clinical trials. The Research Nursing/Data Management Unit provides the centralized function of advising and assisting investigators in patient eligibility assessments, data quality control and oversight. The Cancer Center has provided a suite of offices located on the 7th floor of the Topping Tower with other offices for staff located throughout the hospital due to growth of clinical research. Satellite offices are located in close proximity to patient care areas at the Los Angeles County + USC Medical Center. CISO has important interactions and coordination of functions with the Biostatistics Core Resource, the Cancer Research Informatics Core (CRIC), and the protocol review and monitoring system (Clinical Investigations and Quality Assurance committees) which provide scientific peer review and quality assurance monitoring of the Center's clinical trials.
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