Protocol Review and Monitoring System

方案审查和监测系统（PRMS）-摘要 KCI的方案审查和监测系统（PRMS）确保严格审查 研究方案，优先考虑整个癌症中心的方案，并监测所有临床 research.在提交给PRMC之前，在每个多个项目内进行第一阶段审查， 纪律小组（MDT），在各自的专业知识和实践领域内优先考虑协议。与 关于协议的优先级，MDT对潜在的激活协议进行预先审查， 确定它们是否是当前开放协议组合的补充，以及它们是否应该迁移到 提交给PRMC。MDT还审查了具有科学意义的方案， 有可能获得足够的收益。该流程消除了PRMC的冗余审查， 提交竞争协议。尽管MDT确定了优先级，但仍对其进行了审查和确认 方案审查和监测委员会（PRMC）。PRMC履行PRMS的主要作用。 PRMC由一系列广泛的互补专业知识组成，重点是高级调查员 来自不同学科和专业的代表，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。委员会成员代表A 足够的规模和专业知识的广度，对所有临床研究进行批判性和公平的科学审查 KCI的癌症患者的治疗方案PRMC提供内部监督的科学价值， 癌症试验，除了确保其临床资源参与，以确保最佳做法， 科学研究和应用。PRMC的职能是对IRB的补充，IRB 重点是保护人类受试者。PRMC不打算重复或重叠 IRB的职责，也不旨在执行稽查或数据和安全性监测功能。 科学审查考虑了特定的基本原理、研究设计、已经在 其他地方和癌症中心的进展，生物统计输入的充分性，以及完成 在合理的时间范围内进行研究。此外，PRMC负责应计监测; 定期审查方案，以评估科学进展，包括应计率，以确保 这项研究的科学目标正在按计划在初步确定的估计时限内完成， 成绩.

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.