Protocol Review and Monitoring

方案审查和监控

• 批准号: 7714243
• 负责人: JOHN CURTIN
• 金额: $ 2.01万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-18 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714243
• 关键词: Address; Caring; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Committee Members; Committee Membership; Conduct Clinical Trials; Data; Development; Diagnostic; Doctor of Medicine; Enrollment; Ensure; Funding; Goals; Institutes; Institution; Intervention; Investigation; Laboratories; Lead; Leadership; Malignant Neoplasms; Measures; Medical center; Mission; Monitor; Oncologic Nursing; Oncology Nurse; Patients; Performance; Pharmacy facility; Physician Executives; Physicians; Play; Policies; Positioning Attribute; Procedures; Process; Protocols documentation; Recruitment Activity; Reporting; Research; Research Activity; Research Ethics Committees; Research Personnel; Resources; Review Committee; Role; Safety; Scientist; Site Visit; Supervision; System; Tumor Biology; Universities; authority; base; cancer care; data integrity; design; medical schools; member; novel; patient safety; programs; research study; translational study

The Protocol Review and Monitoring System (PRMS) for the NYUCI is responsible for evaluating the scientific merit of all cancer-related translational and clinical research studies that take place on the NYU Medical Center campus and those of its affiliates. Once the clinical protocol documentation has been ' completed, the PRMS provides a forum for multi-level review, confirming the scientific merit and programmatic fit, as well as assuring allocation of appropriate research resources. After the NYU School of Medicine Institutional Review Board (IRB) approves the protocol the PRMS provides ongoing oversight of the research activity and the ability of the study to meet research objectives. A central core of the PRMS is the Protocol Review and Monitoring Committee (PRMC). The PRMC membership is drawn from the membership of the NYUCI based on expertise in clinical trial development and conduct of clinical trials, as well as leadership in key clinical positions. Physician members of the Committee represent the different subspecialties who provide care and participate in clinical research within the NYUCI. In addition the PRMS includes bench scientists, biostatisticians, members of the administrative staff of the NYUCI, oncology nursing and the investigational pharmacy. Protocols must be approved by the PRMC before submission to the NYU Institutional Review Board. The PRMC review includes the underlying hypothesis, design, and the likelihood that the trial will lead to clinically meaningful results. The Committee has the added duty to examine and evaluate the priority of the planned research in the context of programmatic aims and the resources available. The PRMC monitors accrual yearly and requires that investigators provide a formal plan to increase enrollment if accrual is < 50% of projected. The PRMC has the authority to close underaccruing trials. Investigator initiated studies are the highest priority for the NYUCI especially those involving novel agents based on laboratory results from NYUCI basic and/or translational scientists. A fifty increase in trials submitted to the PRMC has occurred during the last funding cycle due to the emphasis on clinical research by Senior Leadership.

NYUCI的方案审查和监测系统（PRMS）负责评估 在纽约大学进行的所有癌症相关转化和临床研究的科学价值 医学中心校园及其附属机构。一旦临床方案文件已完成， 完成后，PRMS提供了一个多层次审查的论坛，确认了科学价值， 方案的适合性，以及确保分配适当的研究资源。在纽约大学 医学机构审查委员会（IRB）批准PRMS提供持续监督的方案 研究活动和研究的能力，以满足研究目标。PRMS的核心是 议定书审查和监测委员会（PRMC）。PRMC的成员来自 基于临床试验开发和临床试验实施方面的专业知识，作为NYUCI的成员， 以及关键临床职位的领导能力。委员会的医生成员代表不同的亚专业 他们提供护理并参与NYUCI内的临床研究。此外，PRMS 包括板凳科学家，生物统计学家，NYUCI的行政人员，肿瘤学 护理和研究药物。方案必须在提交给 纽约大学机构审查委员会PRMC综述包括基本假设、设计和 试验将产生具有临床意义结果的可能性。委员会还有一项职责， 审查和评估计划研究的优先事项，在方案目标和 现有资源。PRMC每年监测应计费用，并要求研究者提供正式的 如果应计费用低于计划的50%，则计划增加入组人数。PRMC有权关闭应计不足 审判研究者发起的研究是NYUCI的最高优先级，特别是那些涉及 基于NYUCI基础和/或转化科学家的实验室结果的新型药物。增加了50倍 由于强调临床试验，在上一个资助周期内已向PRMC提交试验 高级领导的研究。