Protocol Review and Monitoring System

项目总结（见说明）： 方案审查和监测系统（PRMS）的目标由马里兰州大学Marlene和Stewart Greenebaum癌症中心（UMCCC）的临床研究委员会（CRC）完成。在提交给机构审查委员会之前，CRC审查所有新的癌症方案的科学价值、方法、人力资源充足性、资金和应计目标的合理性 (IRB)马里兰大学巴尔的摩分校（UMB）的马里兰州医学院的研究人员。CRC确保所有机构制定的方案均已进行专家生物统计规划，并在未进行累积或出现科学或安全性问题时监测所有方案是否提前关闭。CRC根据需要对医疗保险覆盖范围和PI对研究与标准护理程序的确定进行审查。CRC与疾病团体合作，以确保拟议方案与现有方案的工作有适当的优先次序。CRC定期与巴尔的摩市癌症计划的医学主任和临床研究的社区外展联络员Shana Ntiri博士一起考虑服务不足的少数民族对UMCCC协议的实际增加，以确保至少与UMCCC的流域人口概况一致。CRC审查拟议数据安全监测（DSM）计划的充分性，并规定DSM/质量保证委员会审查的频率和强度。在2009日历年（CY），CRC审查了61项方案：7项按书面形式批准; 42项经微小修改批准; 8项经重大修改后获得批准，需要再次审查; 2项因审查过程中提出的问题而推迟重新审议; 2项未获批准。对于风险最小的非干预性研究，有一个快速审查程序;该程序在2009年批准了9项研究。如果没有放射肿瘤学的治疗意图，完整的CRC不会直接审查技术相关方案。 这些审查被委托给CRC的一个专门小组委员会，即技术研究审查委员会。在2009年期间，对113项试验进行了应计监测，目标是纠正措施方案，这些方案的应计速度不足以表明在3至5年的时间框架内成功完成。发出了23封警告信。截至2010年8月，儿童权利委员会通过这一进程结束了8项议定书。

PROJECT SUMMARY (See instructions): The goals of the Protocol Review and Monitoring System (PRMS) are accomplished by the Clinical Research Committee (CRC) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). CRC reviews all new cancer protocols for scientific merit, methodology, adequacy of human resources, funding, and reasonableness of accrual goals before submission to the Institutional Review Board (IRB) of the University of Maryland School of Medicine at the University of Maryland-Baltimore (UMB). CRC ensures for all institutionally originated protocols that expert biostatistical planning has occurred, and monitors all protocols for early closure if accrual is not proceeding or if scientific or safety issues arise. CRC provides review as needed of Medicare coverage and PI determinations of research versus standard of care procedures. CRC works with disease groups to ensure proper prioritization for effort of proposed versus existing protocols. CRC considers the actual accrual of underserved minorities to UMGCC protocols on a periodic basis with Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program and community outreach liaison for clinical research, to ensure at least congruence with UMGCC's catchment demographic profile. CRC reviews the adequacy of the proposed Data Safety Monitoring (DSM) plan and stipulates the frequency and intensity of review by the DSM/Quality Assurance Committee. During calendar year (CY) 2009, CRC reviewed 61 protocols: 7 were approved as written; 42 were approved with minor modifications; 8 were approved with major modifications and required another review; 2 were deferred for reconsideration because of issues raised by the review process; and 2 were disapproved. An expedited review process exists for minimal risk non-interventional studies; that process approved nine studies in CY2009. The full CRC does not directly review technology-related protocols without treatment intent from Radiation Oncology. Such reviews are delegated to a specialized subcommittee of CRC, the Technology Research Review Committee. During CY2009, 113 trials were monitored for accrual, targeting for corrective action protocols that were not accruing at a rate suggesting successful completion within a 3- to 5-year time frame. Twenty three warning letters were issued. As of August 2010, CRC had closed eight protocols as a result of this process.