Protocal 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 ICommittee[中国证监会]及其执行委员会[EC]共同行动审查所有与癌症相关的临床 国际议定书的科学价值和监测科学进步，包括应计费率。自上次PRMS以来 1999年，中国证监会重组为两个小组，以便更快地进行方案审查 并细化和明确了科学进步和优先程序的标准。中国证监会由 在代表所有OSUCCC项目的24名成员中，包括临床和基础研究人员， 生物统计学家，药剂师，一名病理学家，一名研究护士和两名患者倡导者。在每两个月一次的会议上， 中国证监会对当地调查人员发起的所有与癌症有关的临床方案进行全面的科学审查 或制药业赞助商。OSU癌症审查前需经中国证监会批准 院校检讨委员会。正式审查需要三名成员，其中一人必须是 生物统计学家。审查员坚持审查模板，包括科学假设和理论基础； 试验设计、患者纳入和排除标准、治疗计划和统计考虑 确保符合所有评审标准。2003年间，审查了60项新议定书，产生了12项[20%] 以书面形式批准，40[67%]按规定批准，8[13%]延期或撤回。正在进行中 每六个月就会监测一次研究的科学进展。应计项目不足的定义是未能达到 在六个月内积累超过50%的年度权责发生制目标。世界银行集团执行委员会 中国证监会7名成员每月开会，指派审查员对提交的研究进行审查，并协助证监会 确定研究优先事项和监测科学进步。如果有相互竞争的协议，欧共体 根据疾病专门委员会的建议确定方案的优先顺序[即乳房、肺、 血液学等)与研究调查员合作。中国证监会终止未表明 采取纠正措施或未能达到公认的质量控制标准后，有足够的应计利润 基于正式审计。

The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review ICommittee [CSRC] and its Executive Committee [EC] that act together to review all cancer-related clinical IProtocols for scientific merit and to monitor scientific progress including accrual rates. Since the last PRMS lapproval in 1999, the CSRC has been reorganized into two teams to facilitate more rapid protocol review and has refined and clarified criteria for scientific progress and prioritization procedures. The CSRC consists of 24 members representing all OSUCCC programs and includes clinical and basic researchers, biostatisticians, pharmacists, a pathologist a research nurse and 2 patient advocates. At bimonthly meetings, the CSRC performs full scientific reviews of all cancer-related clinical protocols initiated by local investigators or pharmaceutical industry sponsors. CSRC approval is required prior to review by the OSU Cancer Institutional Review Board. Formal reviews are required by three members, one of who must be a biostatistician. Reviewers adhere to a review template that includes scientific hypothesis and rationale; experimental design, patient inclusion and exclusion criteria, treatment plan, and statistical considerations to ensure that all review criteria are met. During 2003, 60 new protocols were reviewed resulting in 12 [20%] approved as written, 40 [67%] approved with stipulations, and 8 [13%] deferred or withdrawn. Ongoing studies are monitored for scientific progress every six months. Inadequate accrual is defined as failure to accrue more than 50% of the annual accrual goals over a six-month period. The Executive Committee of seven CSRC members meets monthly to assign reviewers to submitted studies and to assist the CSRC in determining study priorities and in monitoring scientific progress. If there are competing protocols, the EC prioritizes the protocol based on the recommendation of disease specific committees [i.e. Breast, Lung, Hematology, etc.] in collaboration with the study investigator. The CSRC terminates studies that do not show adequate accrual after corrective measures are taken, or fail to meet accepted standards of quality control based on formal audits.