Protocol Review and Monitoring System (PRMS)

方案审查和监测系统的目标是确保科学质量， 患者安全。PRMS提供科学，研究和资源方面的内部监督， 所有的癌症临床试验此外，它还负责确定审判的优先次序。在斯坦福大学， PRMS由两个委员会组成：科学审查委员会（SRC）和数据与安全委员会（DSASS） 监测委员会。 2004年春天，苏珊·诺克斯博士，M.D.被任命为PRMS的学院主任， 沿着的还有米里亚姆·比肖夫，硕士，MBA，设施总监、PRMS结构、委员会和 制定了标准作业程序。PRMS提供管理基础设施 其执行委员会负责指导两个委员会的运作。桑德拉 Horning，医学博士，担任SRC的主席。Robert Carlson，医学博士是SRC的副主席苏珊 诺克斯博士，M.D.主持DSMC。她是由Sandhya Srinivas，医学博士协助。从9月开始 2004年，PRMS从医学院获得资金，聘请2名全职员工;一名行政人员 主任和助理。还为主任和委员会主席提供了部分资金。 各委员会都有自己的标准作业程序（作为附件列入）， 2005年4月开始运营。 SRC由35人组成，每月开会两次，审查所有有癌症患者参加的试验。 所有综合癌症中心的研究都由疾病管理小组进行审查和优先排序 在SRC审查之前。研究报告可以同时提交给斯坦福大学的行政小组 医学研究中的人类受试者，称为机构审查委员会（IRB）。的prm 行政部门与IRB密切合作，以确保所有研究都得到双方的审查和批准。 在研究开始之前，组织应进行累积。SRC监测研究累积和进展， 每年的基础上。 由18人组成的DSMC每月举行一次会议，审查受监测的由制药商发起的研究， 不良事件报告。DSMC可以建议SRC关闭研究。SRC拥有 有权根据其审查或与 DSMC的建议。

The goal of the Protocol Review and Monitoring System (PRMS) is to ensure scientific quality and patient safety. The PRMS provides internal oversight of the scientific, research, and resource aspects of all cancer clinical trials at the center. Additionally it is responsible for prioritization of trials. At Stanford, the PRMS consists of two committees: the Scientific Review Committee (SRC) and the Data and Safety Monitoring Committee (DSMC). In the spring of 2004, Susan Knox, Ph.D., M.D. was appointed the Faculty Director of the PRMS and along with Miriam Bischoff, M.S., M.B.A., Facility Director, the PRMS structure, committees, and standard operating procedures were developed. The PRMS provides the administrative infrastructure and its Executive Committee provides the directions for the operations of the two committees. Sandra Horning, M.D., serves as the Chair of the SRC. Robert Carlson, M.D. is the Vice Chair of the SRC. Susan Knox, Ph.D., M.D. chairs the DSMC. She is assisted by Sandhya Srinivas, M.D. Beginning in September 2004, the PRMS received funding from the School of Medicine to hire 2 FTE's; an Administrative Director and an Associate. Partial funding for the Director and Committee Chairs was also provided. The committees, each with its own standard operating procedures (included as an attachment) became operational in April, 2005. The 35-person SRC meets twice per month and reviews all trials that have cancer patients enrolled. All Comprehensive Cancer Center studies are reviewed and prioritized by a disease management group prior to SRC review. Studies can be submitted simultaneously to the Stanford's Administrative Panels on Human Subjects in Medical Research, referred to as the Institutional Review Board (IRB). The PRMS administration works closely with the IRB to assure that all studies are reviewed and approved by both organizations prior to opening the study to accrual. The SRC monitors study accrual and progress on an annual basis. The 18-person DSMC meets once per month to review monitored investigator-initiated studies and adverse event reports. The DSMC can recommend that a study be closed to the SRC. The SRC has the authority to close non-performing studies based upon its review or its agreement with the recommendation of the DSMC.