Protocol Review and Monitoring System

协议审查和监测系统(PRMS).摘要 KCI的议定书审查和监测系统(PRMS)确保严格审查 研究方案，整个癌症中心方案的优先顺序，并监测所有临床的进展 研究。在提交给PRMC之前，在每个多- 纪律小组(MDT)，他们在各自的专业知识和实践领域内确定协议的优先顺序。使用 关于协议的优先顺序，MDT对激活的潜在协议进行预审查，以 确定它们是否补充了当前的开放协议组合，以及它们是否应该 转送至临立会。MDT还审查了具有科学意义的方案和 获得足够应计利润的可能性。这一过程消除了PRMC的重复审查，并减少了 提交相互竞争的议定书。尽管MDT确定了优先顺序，但会对其进行审查和确认 由议定书审查和监测委员会(PRMC)提供。PRMC履行PRMS的主要角色。 PRMC由一系列互补的专业知识组成，重点是高级调查人员 来自不同学科和专业的代表以及生物统计和生物信息学的代表 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。该委员会的成员代表一个 足够的规模和广度的专业知识来对所有临床研究进行严格和公平的科学审查 KCI涉及癌症患者的协议。PRMC对科学价值提供内部监督 癌症试验除了确保其临床资源得到利用外，还确保 科学努力和应用。PRMC的职能与IRB的职能相辅相成，后者 重点是对人类主体的保护。PRMC的目的不是重复或重叠 内部审查委员会的职责，也不打算执行审计或数据和安全监测职能。 科学审查考虑到特定的理论基础、研究设计、已有研究的重复 其他地方和癌症中心的进展，生物统计学投入的充分性，以及完成 在合理的时间框架内进行研究。此外，PRMC负责应计情况监测； 定期审查议定书，以评估科学进展，包括应计比率，以确保 这项研究的科学目标正在按部就班地在最初确定的预计时间内完成 呈件。

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.