Core--Protocol Review and Monitoring System

核心--方案审查和监控系统

• 批准号: 7038858
• 负责人: JOHN C RUCKDESCHEL
• 金额: $ 3.64万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7038858
• 关键词: biomedical facility; clinical trials; data management; health science research analysis /evaluation

The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee scientific cancer research involving cancer patients in the facilities of the institutions that define the Karmanos Cancer Institute. The main objectives of the monitoring system include the following: 1) review the scientific merit of cancer research protocols; 2) ensure prioritization of therapeutic cancer protocols according to KCIs scientific priorities; 3) monitor scientific progress. The committee is composed of a complementary mix of senior and junior investigators from various disciplines, and specialities, as well as representatives from the Biostatistical Core, nursing and physician extenders, and administrative support staff from the CTO. The members of the committee represent a sufficient size, and breadth of expertise to conduct a critical, fair scientific review of all clinical research protocols involving cancer patients in the institutions comprising the Cancer Center. The PRMS provides internal oversight of the scientific and research aspects of the cancer trials, in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMS is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects. The PRMS is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. The PRMS evaluates all cancer clinical trials, whether derived and supported from institutional sources or from industry. However, the PRMS does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame.

方案审查和监测系统（PRMS）于20世纪90年代初首次实施，以监督涉及Karmanos癌症研究所机构设施中癌症患者的科学癌症研究。监测系统的主要目标包括：1）审查癌症研究方案的科学价值; 2）确保根据KCI的科学优先事项确定治疗癌症方案的优先次序; 3）监测科学进展。该委员会由来自不同学科和专业的高级和初级研究人员以及来自生物统计核心、护理和医生扩展人员的代表以及CTO的行政支持人员组成。该委员会的成员代表了足够的规模和专业知识的广度，可以对癌症中心机构中涉及癌症患者的所有临床研究方案进行严格，公正的科学审查。PRMS提供对科学和 除了确保其临床资源用于确保科学努力和应用的最佳实践外，还负责癌症试验的研究方面。PRMS的功能是对机构审查委员会的补充，后者侧重于保护人类受试者。PRMS预期不会重复或重叠IRB的职责，也不会执行稽查或数据和安全性监测功能。PRMS评估所有癌症临床试验，无论是来自机构来源还是来自行业。然而，PRMS并不重复 传统的同行评审，包括由各种NIH机制支持的协议（例如，R 01、U 01、P01、U10和P50），以及NCI癌症治疗评估计划批准的临床研究方案。科学审查考虑了具体的理由、研究设计、与其他地方已在进行的研究的重复、生物统计输入的充分性以及在合理时间范围内完成研究的可行性。