CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

说明：方案审查和监测系统，根据 迈克尔·布克曼医学博士的领导，已经被大幅修改， 对先前网站评论的批评的回应。PRMS包括 研究审查委员会（RRC），它提供的主要机制， 对新的和正在进行的临床研究方案进行科学评估，并已 有权启动和关闭所有临床研究， 机构审查委员会（IRB）。协调行政支助 通过PRMS的另一个组成部分，礼宾管理办公室， 便利工作人员分配，广泛考虑资源利用情况， 方案工作人员审查每项新研究的操作细节。的prm 直接向医学科学高级副总裁Ozols博士报告。 在上一个授予期间，发生了重大变化，包括： （a）制定提交和审查 方案; B）增加与IRB的书面沟通; c）扩大 在中央关系数据库中收集应计数据; d）强制性 对所有正在进行的研究进行年度科学审查; e）自动生成 方案特定年度审查材料;审查所有方案修订案; 和f）生物统计学家早期参与方案设计和批准， 在RRC上发布之前。 1996年，该系统又进行了一次同行审查， 这是上一次全面审查的建议，并已获得批准。

Description: The Protocol Review and Monitoring System (PRMS), under the leadership of Michael Bookman M.D., has been substantially modified in response to the critique of the previous site review. The PRMS includes the Research Review Committee (RRC), which provides the primary mechanisms for scientific evaluation of new and ongoing clinical research protocols, and has the authority to activate and close all clinical studies in conjunction with the Institutional Review Board (IRB). Administrative support is coordinated through another element of PRMS, the Protocol Management Office, which facilitates staff assignments, broad consideration of resource utilization and protocol staff review of operational details for each new study. The PRMS reports directly to the Senior Vice President for Medical Science, Dr. Ozols. During the last granting period, significant changes have occurred, including: a) the development of standardized forms for submission and review of protocols; b) increased written communication with the IRB; c) expanded collection of accrual data in a centralized relational database; d) mandatory annual scientific review of all active studies; e) automated generation of protocol-specific annual review materials; review of all protocol amendments; and f) early involvement of biostatisticians in protocol design and approval, prior to presentation at RRC. The PRMS underwent an additional peer review in 1996, consequent upon recommendations of the previous full site review, and was approved.