Clinical Trials Management Shared Resource

临床试验管理共享资源（CTMSR）由Raymond P. Perez医学博士领导，提供全面、集中的支持服务，涵盖癌症临床试验从概念到手稿的整个生命周期，并确保成功开展这些试验所需的患者群体和资源符合所有联邦、州和地方法规。35.6名FTE资源人员管理116项临床方案（19项由机构研究者发起，31项由工业部门发起，65项由合作团体发起）。CTMSR在职能上分为四个不同的小组：(1)研究实施及规管遵从（11 FTE）负责项目发展/管理及规管事务，并为吉隆坡大学校规审查及监察系统提供行政支援；(2)研究财务（2 FTE）提供全面的预算制定、主动协议的财务管理和研究账单合规；(3)临床试验（17.6 FTE）提供研究护理、研究协调和数据管理协调；(4)研究保证（FTE）提供临床研究的监测、审计和质量保证/控制（QA/QC）监督，并在行政上支持KUCC数据和安全监测委员会。自2006年以来，CTMSR使KUCC的临床试验增加了近5倍，特别是机构研究者发起的试验（IIT），目前占所有治疗登记的近63%。其他操作重点包括开发和改进整个资源的标准操作程序，特别是财务管理，其中流程改进产生了可持续的业务模型，并支持多个附属站点的本地和区域协作。总之，CTMSR促进了KUCC研究者驱动的临床研究的显著增长，同时实施和管理具有成本效益的流程，以确保研究活动具有科学价值，保护安全，维护科学完整性，并在财政上健全。

The Clinical Trials Management Shared Resource (CTMSR) is led by Raymond P. Perez, MD and provides comprehensive, centralized support services that span the life cycle of cancer clinical trials from concept through manuscript, and assures that the patient population and resources needed to successfully conduct these trials in compliance with all federal, state and local regulations are in place. A resource staff of 35.6 FTE manage a portfolio of 116 clinical protocols (19 institutional investigator-initiated, 31 industrial, and 65 from cooperative groups). The CTMSR is functionally organized into four distinct groups: (1) Study Implementation and Regulatory Compliance (11 FTE) provides project development/management and regulatory affairs functions, and administrative support for the KUCC Protocol Review and Monitoring System; (2) Research Finance (2 FTE) provides comprehensive budget development, financial management for active protocols, and research billing compliance; (3) Clinical Trials (17.6 FTE) provides research nursing, study coordination, and data management coordination; and, (4) Research Assurance (1 FTE) provides monitoring, auditing, and quality assurance/control (QA/QC) oversight of clinical research and administratively supports the KUCC Data and Safety Monitoring Committee. The CTMSR has enabled a nearly 5-fold increase in clinical trials accrual at KUCC since 2006, particularly to institutional investigator-initiated trials (IIT) that now account for almost 63% of all therapeutic enrollments. Additional operational highlights include development and improvement of standard operating procedures across the resource, particularly for financial management, where process improvements yielded a sustainable business model, and support for local and regional collaborations at multiple affiliated sites. In summary, the CTMSR has facilitated significant growth of investigator-driven clinical research at KUCC, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, protect safety, maintain scientific integrity, and are fiscally sound.