Protocol Review and Monitoring System (PRMS)

议定书审查和监测系统的目标是确保科学质量和 病人安全。PRMS提供对科学、研究和资源方面的内部监督 所有癌症临床试验都在该中心进行。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 监督委员会(DSMC)。 2004年春，苏珊·诺克斯博士，医学博士被任命为PRMS的系主任，并 与设施主任Miriam Bischoff，M.S.，M.B.A.一起，PRMS结构，委员会和 制定了标准的操作程序。PRMS提供管理基础设施 其执行委员会为这两个委员会的运作提供指导。桑德拉 霍宁，医学博士，担任SRC主席。罗伯特·卡尔森医学博士是SRC副主席。苏珊 诺克斯博士，医学博士，dsmc主席。她得到了Sandhya Srinivas医学博士的帮助，从9月份开始 2004年，PRMS从医学院获得资金，聘请了2名全职员工；行政 董事和一名合伙人。还为主任和委员会主席提供了部分资金。 每个委员会都有自己的标准操作程序(作为附件包括在内)，成为 2005年4月投入使用。 由35人组成的SRC每月召开两次会议，审查所有纳入癌症患者的试验。 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，简称机构审查委员会(IRB)。PRMS 行政当局与内部评审委员会紧密合作，确保所有研究均经双方审阅及批准。 组织在研究开始前要进行应计。SRC监测研究的收益和进展情况 按年计算。 由18人组成的dsmc每月召开一次会议，审查受监测的调查员发起的研究和 不良事件报告。Dsmc可以建议一项研究不对src开放。SRC拥有 基于对不良研究的审查或与 Dsmc推荐。

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.