Protocol Review and Monitoring System

OSUCCC的方案审查和监测系统（PRMS）包括临床科学审查 在IRB之前审查所有新的癌症相关临床方案的科学价值的委员会[CSRC] 提交并监测正在进行的研究的科学进展，包括累积率。证监会正在 组织成两个小组，以便每月安排两次会议，从而便利快速礼宾 审查.中国证监会由35名成员组成，代表了6个OSUCCC研究项目。其 会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 在每两个月一次的会议上，中国证监会对所有与癌症相关的临床方案进行全面的科学审查 由当地研究者或制药行业申办者发起。方案需要中国证监会批准 在OSU癌症机构审查委员会审查之前。每个方案由三个CSRC审查 成员，其中一人必须是生物统计学家，除了药房审查。评论家遵循书面 要求分析科学假设和原理、实验设计 患者入选和排除标准、治疗计划和统计学考虑。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，该委员会是一个小组委员会 中国证监会。实施FRC以促进试验激活并确认适当的 优先化。财务汇报局并不评估该方案的科学性，这是留给证监会 上级委员会，而是评估这些必要的资源，以执行这些资源的可用性， 议定书中国证监会执行委员会（EC）对中国证监会进行监督。它由七个证监会组成 成员每月开会，将新提交的资料分配给成员进行审查，审查方案应计费用 并确保遵循协议优先级规则。中国证监会坚持一套明确的标准 进行权责发生制监测和确定审判优先次序。正在进行的研究未显示充分的累积或失败 根据正式审计结果，为达到公认的质量控制标准而终止。2009年，进行了8项审判， 因低应计而关闭：PI关闭2个，中国证监会关闭6个。欧盟委员会还可以对以下项目进行快速审查： 适当的研究（例如，回顾性审查）。2009年，证监会审核新方案176项 结果：书面批准32例（18%），有规定批准64例（37%）， (11%）被推迟，3项（2%）被撤回，57项（32%）方案接受了外部科学审查 得到了承认。28项非干预性方案也以快速方式获得批准 证监会伦理委员会。

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.