Clinical Protocol and Data Management

12.0摘要：临床方案和数据管理 UMCCC的临床方案和数据管理（CPDM）部分包括 临床研究管理办公室（CRMO），以前定义为临床研究共享服务， 2011年CCSG应用程序，以及支持其 运营CRMO与各种UMCCC疾病组的研究人员一起参与，或协助 根据要求，在设计、审查、 实施、监测和报告所有临床方案。这项工作包括与 UMB的机构审查委员会（IRB）、NCI中心IRB、临床研究委员会（CRC; 作为UMCCC的方案审查和监测系统），以及UMCCC数据安全 监测/质量保证委员会（DSM/QAC）以及其他监测和审计实体。CrMo 利用OnCore数据库跟踪所有患者的入组情况，完成行业病例报告表- 申办试验并将数据输入国家临床试验网络的适当数据库， 实验治疗药物临床试验网络NCI-Sponsored Studies。 在2010 -2014年的最后一个授权期间，CRMO每年支持200-250个协议， 共出版112本。UMCCC DSM/QAC为以下人员提供数据安全监测功能： 没有外部数据和安全监测委员会（DSMB）的方案。DSM/QAC每年 审查所有“大于最小风险”的累积患者的安全性信息（根据UMB IRB标准） 制药商发起的任何阶段试验、所有I期试验和选定的行业II期试验， FDA指定的DSMB，包括UMCCC是其发起的多机构临床试验 协调中心。在2014财年，支持CPDM的成本为3，159，534美元，其中157，278美元来自 CCSG。在2014财政年度，支持DSM/QAC的成本为776，002美元，其中78，500美元来自 CCSG。

12.0 Abstract: Clinical Protocol and Data Management The Clinical Protocol and Data Management (CPDM) component of UMGCC comprises the personnel in the Clinical Research Management Office (CRMO), formerly defined as the Clinical Research Shared Service in the 2011 CCSG application, and the resources, including database and technical staff, supporting its operations. The CRMO participates with investigators in the various UMGCC Disease Groups or assists research support staff housed in other departments in UMB, as requested, in the design, review, implementation, monitoring, and reporting of all clinical protocols. This effort includes interactions with the Institutional Review Board (IRB) of UMB, the NCI Central IRB, the Clinical Research Committee (CRC; functioning as the Protocol Review and Monitoring System) of UMGCC, and the UMGCC Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) as well as other monitoring and auditing entities. CRMO utilizes the OnCore database to track enrollment of all patients, completing case report forms for industry- sponsored trials and entering data into appropriate databases for National Clinical Trials Network and Experimental Therapeutics Clinical Trials Network NCI-sponsored studies. During the last granting period encompassing CY2010–2014, the CRMO supported 200–250 protocols/year, resulting in 112 publications. The UMGCC DSM/QAC serves the data safety monitoring function for those protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually reviews safety information for accrued patients to all “greater than minimal risk” (according to UMB IRB criteria) investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor-appointed DSMB, including multi-institutional investigator-initiated trials for which UMGCC is the coordinating center. During FY2014, costs to support CPDM were $3,159,534, of which $157,278 were from the CCSG. During FY2014, costs to support the DSM/QAC were $776,002, of which $78,500 were from the CCSG.