PROTOCOL REVIEW AND MONITORING

描述（由申请人提供）：PRMS办公室负责监督PRMS委员会开展的方案审查过程。 这些职责包括与此过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已批准和激活的方案的应计费用和科学进展。 这一过程需要每年对应计费用和科学进展进行审计，并与计划的应计费用进行比较，与临床研究副主任和PRMS委员会一起审查这些结果，并与临床研究副主任一起评价PI的答复。 PRMS委员会-在UAB癌症中心运行的方案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委员会对拟议的临床试验进行科学评估，建立适合中心科学资源和患者人群的研究优先级，并监测所有活动方案的状态和进展。 我们的临床研究活动范围广泛，但优先考虑癌症中心教师发起的试验和创新的转化研究方案。 PRMS委员会的正式职责总结如下：审查将在伯明翰的亚拉巴马大学进行的所有癌症相关方案，并就方案的科学质量、可行性、与癌症中心目标的一致性以及是否存在竞争性研究提出建议。 根据上述考虑，提供有关批准的建议（有或无修改），或 不赞成进度报告-在本供资期内，每年审查的议定书数量增加了42%。 为了便于审查数量增加的研究报告，PRMS委员会在两个委员会中每月举行两次会议，而不是一次会议。 在上一个报告期（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，对25项议定书仅进行了优先审查（国家议定书）; 21项议定书是机构议定书，5项其他同行审查议定书，47项是药物议定书。 在科学价值审查的方案中，26%按书面形式批准，46%需要轻微修订，26%需要重大修订，2%不批准。 在上一个报告期内，我们进行了51次应计和科学进展审查：68%被批准继续，20%被试用，12%因进展不足而关闭。

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.