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办公室负责监督由PRMS委员会进行的方案审查过程。这些职责包括与该流程相关的管理和记录保存任务。此外，PRMS办公室还负责审查所有批准和启动的议定书的累积和科学进展情况。这一过程需要每年对应计和科学进展进行审计，并与计划应计进行比较，与临床研究副主任和PRMS委员会一起审查这些发现，并与临床研究副主任一起评估PI的答复。PRMS委员会--在UAB癌症中心运作的议定书审查和监测系统--利用PRMS委员会提供同行审查和批准-不批准建议。PRMS委员会提供对拟议的临床试验的科学评估，建立与该中心的科学资源和患者群体相适应的研究优先事项，并监测所有现行方案的状态和进展。我们的临床研究活动范围很广，但优先考虑癌症中心教职员工发起的试验和创新的转化研究方案。对PRMS委员会的正式指控总结如下：审查将在伯明翰阿拉巴马大学进行的所有与癌症相关的方案，并就科学质量、可行性、方案与癌症中心目标的一致性以及是否存在相互竞争的研究提出建议。基于上述考虑，提供有关批准的建议(修改或不修改)或 不赞成。进展报告--在本供资期间，每年审查的议定书数量增加了42%。为便于审查这一增加的研究数量，项目管理委员会在两个委员会中举行了两次会议，而不是每月一次。在上次报告所述期间(2003年3月1日至2004年2月28日)，对74项议定书进行了科学价值审查，25项议定书仅作为优先议定书(国家议定书)；21项议定书是制度性议定书，5项其他议定书是同行审评的议定书，47项议定书是药学议定书。在对科学价值进行审查的方案中，26%的方案以书面形式获得批准，46%的方案需要进行小幅修改，26%的方案进行重大修改，2%的方案不获批准。 在上一次报告所述期间，我们对应计和科学进展进行了51次审查：68%的审查获准继续进行，20%的审查处于试用期，12%的审查因进展不足而关闭。