Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 8558329
• 负责人: Thomas James Lynch
• 金额: $ 8.49万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8558329
• 关键词: Cancer Center Support Grant; Cancer Etiology; Cancer Patient; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Comprehensive Cancer Center; Conduct Clinical Trials; Conflict (Psychology); Creativeness; Data; Databases; Disease; Electronics; Ensure; Evaluation; Event; Goals; Growth; Human; Informed Consent; Institutional Review Boards; Instruction; Investigation; Knowledge; Life Cycle Stages; Malignant Neoplasms; Mission; Monitor; Names; Patients; Peer Review; Process; Protocols documentation; Recommendation; Records; Research; Research Design; Research Priority; Resource Sharing; Resources; Review Committee; Role; Safety; Services; System; Universities; Yale Cancer Center; authority; cancer research center director; improved; meetings; programs; quality assurance; repository

The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit and progress of all clinical studies at the Yale Cancer Center (YCC). The PRMS evaluation process occurs prior to submission to the Yale University institutional review board (known as the Human Investigation Committee or HIC) and is required for IRB approval. The PRMS process is complementary to the IRB review and does not overlap or duplicate the responsibilities of the IRB. There are two major committees of the PRMS that provide for clinical research review and oversight: the Clinical Research Steering Committee (SC), and the Protocol Review Committee (PRC). Although each Committee has a unique role, when combined these are aligned to ensure that research concepts and protocols move through the system in a timely fashion, receive high-quality peer review and monitoring, and that the research protocol is consistent with YCC clinical research priorities. Proposed protocols are initially discussed in disease teams and then presented to the SC where they are assessed for feasibility and consistency with overall YCC goals. After receiving SC approval the study then proceeds to the PRO for full scientific and biostatistical review, priority scoring and assessment of the data and safety monitoring plan. After approval the PRMS provides ongoing review to ensure adequate accrual, scientific progress and continued consistency with overall YCC goals. The SC conducts reviews of each disease team portfolio at six month intervals to assess progress, rates of accrual and continued consistency with the priorities of the YCC. The SC then makes recommendations for closure to the PRC if studies are not progressing towards the scientific objectives. The PRC has the authority to close studies. In Fiscal Year 2012, a total of 94 new protocols were evaluated by the PRMS for merit, and 201 protocols were monitored for scientific progress.

方案审查和监测系统（PRMS）监督并确保耶鲁癌症中心（YCC）所有临床研究的科学价值和进展。PRMS评价过程在提交给耶鲁大学机构审查委员会（称为人类调查委员会或HIC）之前进行，并需要IRB批准。PRMS过程是对IRB审查的补充，不会与IRB的职责重叠或重复。PRMS有两个主要委员会负责临床研究审查和监督：临床研究指导委员会（SC）和方案审查委员会（PRC）。虽然每个委员会都有一个独特的作用，但当它们结合在一起时，它们会保持一致，以确保研究概念和方案及时通过系统，接受高质量的同行评审和监督，并且研究方案与YCC临床研究优先事项一致。提议的方案首先在疾病小组中讨论，然后提交给SC，在那里评估方案的可行性和与YCC总体目标的一致性。在获得SC批准后，研究将继续进行PRO，以进行全面的科学和生物统计学审查、优先评分和数据评估以及安全性监测计划。批准后，PRMS提供持续审查，以确保充分的应计费用、科学进展和与YCC总体目标的持续一致性。SC每隔六个月对每个疾病团队组合进行审查，以评估进展情况、累积率以及与YCC优先事项的持续一致性。如果研究没有朝着科学目标取得进展，SC然后向PRC提出关闭的建议。中华人民共和国有权关闭研究。在2012财政年度，PRMS共对94项新协议进行了价值评估，并对201项协议进行了科学进展监测。