Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10553200
• 负责人: LAWRENCE E FLAHERTY
• 金额: $ 10.65万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-08 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553200
• 关键词: Area; Authorization documentation; Bioinformatics; Biometry; Cancer Center; Cancer Center Support Grant; Cancer Patient; Cancer health equity; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Committee Members; Complement; Data; Discipline; Ensure; Institutional Review Boards; Malignant Neoplasms; Mission; Monitor; Pharmacology; Process; Protocols documentation; Research; Research Design; Research Personnel; Research Support; Resources; Role; Safety; Support System; System; Time; anticancer research; authority; community engagement; human subject protection; interest; medical specialties; metabolomics; multidisciplinary

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) – ABSTRACT The Protocol Review and Monitoring System (PRMS) at KCI ensures rigorous review of the scientific merit of research protocols, prioritization of protocols across the Cancer Center, and monitors progress of all clinical research. Prior to submission to the PRMC, a first stage review is conducted within each of the Multi- Disciplinary Teams (MDT), who prioritize protocols within their respective area of expertise and practice. With respect to prioritization of protocols, the MDT conducts a pre-review of potential protocols for activation to determine whether they complement the current portfolio of open protocols and whether they should move forward for submission to the PRMC. The MDT also reviews the protocols for scientific interest and the likelihood of attaining adequate accrual. This process eliminates redundant reviews by the PRMC and reduces submission of competing protocols. Although the MDT identifies the prioritization, it is reviewed and confirmed by the Protocol Review and Monitoring Committee (PRMC). The PRMC fulfills the primary role of the PRMS. The PRMC is composed of a broad array of complementary expertise with an emphasis on senior investigators from various disciplines and specialties, as well as representatives from the Biostatistics and Bioinformatics Core, Pharmacology and Metabolomics Core, the Clinical Trials Office (CTO), the KCI Network, and the Office of Cancer Health Equity & Community Engagement. The members of the committee represent a sufficient size and breadth of expertise to conduct a critical and fair scientific review of all clinical research protocols involving cancer patients at KCI. The PRMC provides internal oversight of the scientific merit 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 PRMC is complementary to that of the IRB, which focuses on the protection of human subjects. The PRMC 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. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame. Additionally, the PRMC is responsible for accrual monitoring; protocols are reviewed regularly to evaluate scientific progress, including accrual rates, to ensure that the scientific aims of the study are on track for completion in the estimated timeframes indicated at initial submission.

方案审查和监测系统 (PRMS) – 摘要 KCI 的方案审查和监测系统 (PRMS) 确保对科学价值进行严格审查 研究方案、整个癌症中心方案的优先顺序，并监控所有临床进展 在提交给 PRMC 之前，每个多边机构都会进行第一阶段审查。 纪律小组 (MDT)，他们在各自的专业知识和实践领域内优先考虑协议。 关于协议的优先级，MDT 对潜在的协议进行预审查以激活 确定它们是否补充了当前的开放协议组合以及是否应该移动 MDT 还审查了协议的科学利益和用途。 该过程消除了 PRMC 的冗余审查并减少了获得足够应计费用的可能性。 尽管 MDT 确定了优先顺序，但仍会对其进行审查和确认。 由方案审查和监测委员会 (PRMC) 负责。 PRMC 履行 PRMS 的主要职责。 PRMC 由广泛的互补专业知识组成，重点是高级研究人员 来自各个学科和专业的代表，以及来自生物统计学和生物信息学的代表 核心、药理学和代谢组学核心、临床试验办公室 (CTO)、KCI 网络和 癌症健康公平和社区参与办公室。委员会的成员代表 足够规模和广度的专业知识，对所有临床研究进行批判性和公平的科学审查 PRMC 对涉及 KCI 癌症患者的协议进行科学价值的内部监督。 癌症试验除了确保其临床资源用于确保最佳实践 PRMC 的职能与 IRB 的职能是互补的。 PRMC 的重点是保护人类受试者，无意重复或重叠。 IRB 的职责，也不旨在执行审计或数据和安全监控职能。 科学审查考虑了具体的基本原理、研究设计、已有研究的重复 其他地方和癌症中心的进展、生物统计投入的充足性以及完成 在合理的时间范围内进行研究 此外，PRMC 还负责权责发生制监测； 定期审查协议以评估科学进展，包括应计率，以确保 该研究的科学目标有望在最初指出的预计时间范围内完成 提交。