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，用于监督卡马诺斯癌症研究所所属机构设施中涉及癌症患者的科学癌症研究。监测系统的主要目标包括以下内容：1）审查癌症研究方案的科学价值； 2) 根据 KCI 的科学优先顺序确保癌症治疗方案的优先顺序； 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、生物统计核心代表、护理和医师扩展人员以及首席技术官的行政支持人员组成。该委员会的成员具有足够的规模和广泛的专业知识，可以对癌症中心所属机构中涉及癌症患者的所有临床研究方案进行严格、公平的科学审查。 PRMS 提供对科学和技术的内部监督 癌症试验的研究方面，此外还确保其临床资源用于确保科学努力和应用的最佳实践。 PRMS 的职能与机构审查委员会的职能是互补的，机构审查委员会的重点是保护人类受试者。 PRMS 无意重复或重叠 IRB 的职责，也无意执行审计或数据和安全监控功能。 PRMS 评估所有癌症临床试验，无论是来自机构来源还是行业来源和支持。然而，PRMS 不会重复以下结果： 传统的同行评审，包括各种 NIH 机制支持的方案（例如 R01s、U01s、P01s、U10s 和 P50s），以及 NCI 癌症治疗评估计划批准的临床研究方案。科学审查考虑到具体的理由、研究设计、其他地方已经进行的研究的重复、生物统计输入的充分性以及在合理的时间范围内完成研究的可行性。