CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

核心——方案审查和监控系统

• 批准号: 6652222
• 负责人: MICHAEL A BOOKMAN
• 金额: $ 19.62万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6652222
• 关键词: CORE; PROTOCOL; REVIEW; MONITORING; SYSTEM

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.

描述：协议审查和监测系统（PRMS），根据 迈克尔·布克曼医学博士的领导，在 对先前网站审查的批评的回应。 PRMS 包括 研究审查委员会（RRC），它提供了主要机制 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）。协调行政支持 通过 PRMS 的另一个组成部分，即礼宾管理办公室， 促进人员分配、广泛考虑资源利用和 方案工作人员审查每项新研究的操作细节。计划风险管理系统 直接向医学科学高级副总裁 Ozols 博士汇报。 在上一个授予期内，发生了重大变化，包括： a) 制定提交和审查的标准化表格 协议； b) 增加与 IRB 的书面沟通； c) 扩展 在集中式关系数据库中收集应计数据； d) 强制性的 对所有正在进行的研究进行年度科学审查； e) 自动生成 特定于协议的年度审查材料；审查所有议定书修正案； f) 生物统计学家尽早参与方案设计和批准， 在 RRC 演讲之前。 PRMS 于 1996 年接受了额外的同行评审，随后 先前全面现场审查的建议，并获得批准。