Protocol Review & Monitoring System (PRMS)

项目摘要--议定书审查和监测系统 方案审查和监测系统(PRMS)提供对所有临床和 在阿尔伯特·爱因斯坦癌症中心(AECC)进行的翻译研究。执行PRMS功能 由议定书审查和监测委员会(PRMC)发起，这是一个多学科小组，其成员有 在治疗学、药物开发和翻译科学方面的专业知识和经验。PRMC执行一项 完成对所有机构调查人员发起的和行业- 赞助的癌症相关方案。PRMC不重复传统的同行审查，这包括 由国家卫生研究院各机制、其他经批准的资助机构支持的同行评审方案 NCI癌症治疗评估计划或癌症控制方案支持的临床研究方案 覆核委员会。所有NCI发起的协议都经过了之前的同行审查 对可行性和与其他试验的重叠资格进行行政审查。临市局的职能包括 与侧重于保护人类主体的机构审查委员会(IRB)相辅相成， 并与AECC数据安全监测委员会(DSMC)的数据安全监测委员会的数据分离。临立会确保所有 试验有适当的数据安全和监测计划；数据和安全监测职能是 DSMC的责任。初步审查制度包括两个阶段，首先由 面向疾病或形态的临床研究负责人(CRL)和临床研究副主任， 随后由PRMC进行审查。此两阶段评审流程通过以下方式提高效率：(I)减少员工在以下方面的工作量 制定方案和PRMC应用材料，科学价值较低；(Ii)缩短从 对议定书激活的概念批准，以及(3)减少由 委员会审议阶段。在过去3年中(7/1/15-6/30/18)，有442项新的议定书被激活，其中包括306项 干预(15%的机构)和136个不干预(85%的机构)。

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Albert Einstein Cancer Center (AECC). PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group whose members have expertise and experience in therapeutics, drug development, and translational science. The PRMC performs a complete scientific, feasibility, and administrative review of all institutional investigator-initiated and industry- sponsored cancer-related protocols. The PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, and clinical research protocols supported by NCI's Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review for feasibility and overlapping eligibility with other trials. Functions of the PRMC are complementary to the Institutional Review Board (IRB), which focuses on the protection of human subjects, and separate from those of the AECC Data Safety Monitoring Committee (DSMC). The PRMC ensures that all trials have appropriate data safety and monitoring plans in place; data and safety monitoring functions are the responsibility of the DSMC. The system for initial review comprises 2-stages, starting first with approval by a disease or modality-oriented clinical research leader (CRL) and Associate Director for Clinical Research, followed by review by the PRMC. This 2-stage review process increases efficiency by (i) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) decreasing the volume of protocols reviewed by the committee. Over the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional).