Protocol Review and Monitoring System

OSUCCC的方案审查和监测系统[PRMS]由临床科学审查组成 委员会[中国证监会]在IRB之前审查所有与癌症相关的新临床方案的科学价值 提交并监测正在进行的研究的科学进展，包括应计比率。中国证监会是 组织成两个团队，允许每月举行两次会议，从而促进快速协议 复习一下。中国证监会由代表6个OSUCCC研究项目的35名成员组成。它的 成员包括临床和基础研究人员、生物统计学家、药剂师和研究护士。在… 中国证监会每两个月召开一次会议，对所有与癌症有关的临床方案进行全面的科学审查 由当地调查人员或制药行业赞助商发起。协议需经中国证监会批准 在俄亥俄州立大学癌症机构审查委员会审查之前。每项协议都由三个证监会审查 成员，其中一人必须是生物统计学家，除了药房审查。评审员遵循书面的 要求分析科学假设和理论基础、实验设计、 患者纳入和排除标准、治疗计划和统计考虑因素。截至2009年1月，所有 新的研究方案由中国证监会可行性审查委员会(FRC)进行审查，FRC是一个小组委员会 中国证监会的。FRC的实施是为了促进试运行并确认适当 确定优先顺序。FRC不评估该协议的科学方面，这留给了中国证监会 而是评估实施 协议。中国证监会执行委员会(EC)向中国证监会提供监督。它由七个中国证监会组成 每月开会的成员将新提交的内容分配给成员进行审查，审查协议应计 并确保遵守协议优先级规则。中国证监会坚持一套明确的标准 用于应计监测和试验优先次序。那些正在进行的研究没有显示足够的应计利润或失败 为达到公认的质量控制标准，在正式审核的基础上予以终止。2009年，有8项试验是 低应计利润关闭：PI关闭2个，证监会关闭6个。教统会亦可就以下事项进行快速覆核 适当的研究(例如，回顾回顾)。2009年，中国证监会审查了176项新协议 结果如下：书面批准32人(18%)，有规定批准20人(37%) (11%)被推迟，3(2%)被撤回，57(32%)接受外部科学审查 都被承认了。28项非干预性议定书也以快速方式获得批准 由中国证监会发改委。

The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review Committee [CSRC] that reviews all new cancer-related clinical protocols for scientific merit prior to IRB submission and monitors the scientific progress of ongoing studies including accrual rates. The CSRC is organized into two teams to permit a twice monthly meeting schedule and thereby facilitate rapid protocol review. The CSRC consists of 35 members representative of the 6 OSUCCC research programs. Its membership includes clinical and basic researchers, biostatisticians, pharmacists, and research nurses. At its bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval of a protocol is required prior to its review by the OSU Cancer Institutional Review Board. Each protocol is reviewed by three CSRC members, one of whom must be a biostatistician, in addition to pharmacy review. Reviewers follow a written review template that calls for an analysis of the scientific hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations. As of January 2009, all new research protocols undergo review by the CSRC Feasibility Review Committee (FRC), which is a subcommittee of the CSRC. The FRC was implemented to facilitate trial activation and confirm proper prioritization. The FRC does not evaluate the scientific aspects of the protocol, which is left to the CSRC parent committee, but instead evaluates the availability of those resources necessary to implement the protocol. The CSRC Executive Committee (EC) provides oversight to the CSRC. It consists of seven CSRC members that meets monthly to assign new submissions to members for review, to review protocol accrual and ensure that protocol prioritization rules are followed. The CSRC adheres to a set of well-defined criteria for accrual monitoring and trial prioritization. Those ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based on formal audits are terminated. In 2009, 8 trials were closed for low accrual: 2 by the PI and 6 by the CSRC. The EC can also perform expedited reviews for appropriate studies (e.g., retrospective reviews). In 2009, 176 new protocols were reviewed by the CSRC with the following results: 32 (18%) were approved as written, 64 (37%) were approved with stipulations, 20 (11%) were deferred, 3 (2%) were withdrawn and 57 (32%) protocols that received outside scientific review were acknowledged. Twenty-eight non-interventional protocols were also approved In an expedited fashion by the CSRC EC.