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委员会承担的方案审查过程。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启动的方案的应计和科学进展。这一过程需要对应计收益和科学进展进行年度审计，并与计划应计收益进行比较，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委员会为拟议的临床试验提供科学评估，建立适合中心科学资源和患者群体的研究重点，并监测所有有效方案的状态和进展。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：审查将在阿拉巴马大学伯明翰分校进行的所有与癌症相关的协议，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性研究的存在提出建议。基于上述考虑，提供有关批准（有或没有修改）或