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.

协议审查和监测系统（PRMS）监督并确保了耶鲁癌症中心（YCC）所有临床研究的科学优点和进步。 PRMS评估过程发生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，是IRB批准所必需的。 PRMS过程是IRB审查的补充，并且不会重叠或复制IRB的责任。 PRM的两个主要委员会提供了临床研究审查和监督：临床研究指导委员会（SC）和协议审查委员会（PRC）。尽管每个委员会都有独特的作用，但是将这些委员会结合在一起，以确保研究概念和协议及时地通过系统，接受高质量的同行评审和监测，并且该研究方案与YCC临床研究的优先级一致。提议的方案最初是在疾病小组中讨论的，然后介绍给SC，以评估它们的可行性和与整体YCC目标的一致性。在获得SC批准后，该研究将继续前往PRO进行全面的科学和生物统计评论，数据和安全监控计划的优先评分和评估。批准后，PRM提供了持续的审查，以确保足够的应计科学进步并持续与YCC目标一致。 SC以六个月的间隔对每个疾病团队的投资组合进行了评论，以评估进度，应计率和持续与YCC的优先事项一致。然后，如果研究没有发展到科学目标，则SC提出了关闭中心的建议。中国有权关闭研究。在2012财政年度，PRMS总共评估了94种新方案，并监控了201个方案以取得科学进步。