PROTOCOL REVIEW AND MONITORING

方案审查和监控

• 批准号: 7414808
• 负责人: PETER D. EMANUEL
• 金额: $ 13.18万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7414808
• 关键词: Alabama; Cancer Center; Charge; Clinical Research; Clinical Trials; Evaluation; Extramural Activities; Faculty; Funding; Malignant Neoplasms; Minor; Modification; Monitor; Numbers; Nursing Research; Patients; Peer Review; Pharmacologic Substance; Population; Process; Progress Reports; Protocols documentation; Recommendation; Reporting; Research Activity; Research Personnel; Research Priority; Resources; Scientific Evaluation; System; Therapy Clinical Trials; Translational Research; Universities; Writing; base; data management; innovation; novel therapeutics; probation

DESCRIPTION (provided by applicant): The PRMS office is responsible for overseeing the protocol review process which is undertaken by the PRMS Committee. These responsibilities include administrative and record keeping tasks associated with this process. The PRMS office is in addition responsible for reviews of accrual and scientific progress of all approved and activated protocols. This process requires a yearly audit for accrual and scientific progress and comparison with planned accrual, review of these findings with the Associate Director for Clinical Research and the PRMS Committee, and evaluation of the replies from the Pi's with the Associate Director for Clinical Research. The PRMS Committee - The Protocol Review and Monitoring System operational in the UAB Cancer Center utilizes the PRMS Committee to provide peer-review and approval-disapproval recommendations. The PRMS Committee provides scientific evaluation of proposed clinical trials, establishment of research priorities appropriate to the Center's scientific resources and patient populations and monitors the status and progress of all active protocols. Our clinical research activities are broad in scope, but priority is given to Cancer Center faculty initiated trials and innovative translational research protocols. The formal charge to the PRMS Committee is summarized as follows: Review all cancer related protocols which will be undertaken at the University of Alabama at Birmingham, and make recommendations regarding scientific quality, feasibility, consistency of the protocol with Cancer Center objectives, and existence of competing studies. Based upon the above considerations provide recommendations regarding approval (with or without modifications) or disapproval. Progress Report - In this funding period the number of protocols reviewed each year has increased by 42%. To facilitate review of this increased number of studies the PRMS Committee meets twice rather than once monthly in two Boards. In the last reporting period (3/1/03 to 2/28/04), 74 protocols were reviewed for scientific merit and 25 for priority only (National Protocols); 21 protocols were institutional, 5 other peer-reviewed and 47 were pharmaceutical. Of the protocols reviewed for scientific merit, 26% were approved as written, 46% required minor revision, 26% major revision and 2% were disapproved. In the last reporting period, we undertook 51 reviews for accrual and scientific progress: 68% were approved for continuation, 20% were placed on probation and 12% were closed for inadequate progress.

描述（由申请人提供）：PRMS办公室负责监督PRMS委员会进行的协议审查过程。 这些职责包括与此过程相关的管理和记录保留任务。 PRMS办公室还负责审查所有批准和激活协议的应计和科学进步。 此过程需要每年进行应计和科学进步的审计，并与计划的应计，与临床研究副总监和PRMS委员会进行这些发现的审查，并评估PI与临床研究副总监的答复。 PRMS委员会 - 协议审查和监测系统在UAB癌症中心运作，利用PRMS委员会提供同行评审和批准批准建议。 PRMS委员会对拟议的临床试验进行了科学评估，建立适合该中心科学资源和患者人群的研究优先级，并监视所有活跃方案的状态和进步。 我们的临床研究活动的范围很广，但是优先考虑癌症中心的教职员工试验和创新的翻译研究方案。 PRMS委员会的正式指控总结如下：审查所有与癌症相关的方案，这些方案将在伯明翰的阿拉巴马大学进行，并就科学质量，可行性，协议与癌症中心目标的一致性以及竞争研究的存在提出建议。 根据上述考虑，提供了有关批准（有或没有修改）或 不赞成。进度报告 - 在此资助期间，每年审查的协议数量增加了42％。 为了促进对这一增加的研究的审查，PRMS委员会在两个董事会中每月开会两次。 在上一个报告期（03年3月1日至2/28/04）中，审查了74个协议的科学功绩，仅优先考虑25个协议（国家协议）； 21个协议是机构的，其他5个同行评审，47个是药物。 在审查科学功绩的协议中，有26％的人获得书面批准，有46％的人需要次要修订，26％的重大修订和2％的人被拒绝。 在上一个报告期间，我们对应计和科学进步进行了51次评论：68％的持续批准，将20％放置在缓刑中，而12％的审查因进度不足而被关闭。