Protocol Review and Monitoring

方案审查和监控

• 批准号: 7843334
• 负责人: JOHN CURTIN
• 金额: $ 3.54万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7843334
• 关键词: Address; Cancer Center Support Grant; Caring; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Committee Members; Committee Membership; Conduct Clinical Trials; Data; Development; Diagnostic; Doctor of Medicine; Enrollment; Ensure; Ethics; 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; meetings; 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 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 医疗中心校区及其附属机构。一旦临床方案文件已“ 完成后，PRMS 提供了一个多层次审查的论坛，确认科学价值和 计划的配合，以及确保适当的研究资源的分配。纽约大学商学院毕业后 医学机构审查委员会 (IRB) 批准 PRMS 提供持续监督的方案 研究活动和研究实现研究目标的能力。 PRMS 的核心是 方案审查和监测委员会 (PRMC)。 PRMC 的成员来自 NYUCI 会员资格基于临床试验开发和临床试验实施方面的专业知识，如 以及关键临床职位的领导力。委员会的医师成员代表不同的亚专业 他们在 NYUCI 内提供护理并参与临床研究。此外，PRMS 包括实验室科学家、生物统计学家、NYUCI 行政人员、肿瘤学人员 护理和研究药房。方案在提交给 PRMC 之前必须得到 PRMC 的批准 纽约大学机构审查委员会。 PRMC 审查包括基本假设、设计和 该试验产生具有临床意义的结果的可能性。委员会还有额外的职责： 在计划目标和计划背景下审查和评估计划研究的优先顺序 可用资源。 PRMC 每年监控应计情况并要求调查人员提供正式的 如果应计人数<预计的 50%，则计划增加入学人数。 PRMC 有权关闭应计不足的项目 试验。研究者发起的研究是 NYUCI 的首要任务，尤其是那些涉及 基于 NYUCI 基础和/或转化科学家实验室结果的新型药物。增加了五十 由于强调临床，提交给 PRMC 的试验是在上一个资助周期进行的 高级领导的研究。