PROTOCOL REVIEW AND MONITORING SYSTEM

方案审查和监测系统的目的是审查科学价值， 科学优先事项，以及在大学进行的癌症相关研究的科学进展 芝加哥大学和使用UCCRC资源。UCCRC PRMS分为两个委员会， 临床试验审查委员会（CTRC）和科学和应计监测委员会（SAM）， 由临床科学副总监（Mark Ratain博士）和临床 研究咨询委员会（CRAC）。一名协调员为所有三个委员会服务。CTRC 和SAM由来自所有学术单位和学科的UCCRC成员组成， 临床试验的专业知识。反恐委员会每月举行一次会议，主要负责评估 科学价值、严谨性、数据和安全性监测的适当性，以及 在UCCRC目标和资源的背景下进行试验。CTRC和IRB审查同时进行，但 协议激活需要CTRC的完全批准。CTRC审查至少由3人进行， 包括生物统计学家方案可以批准、批准修订、推迟或 不赞成。已经过同行评审的协议（例如，合作组协议，NIH， ACS）有资格进行快速审查;也就是说，它们不需要由全 委员会，而是将由主席或共同主席审查，他们可以选择将它们带到委员会， 如果有具体的问题（例如，设计、优先化）。SAM具有主 负责监测临床试验研究协调委员会批准的研究的科学进展，包括应计、少数 累积，实现研究目标的总体进展，以及确保遵守 方案程序和UCCRC数据和安全性监测要求。SAM每月开会， 并有权关闭那些没有取得足够科学进展的协议， 符合适当的科学或数据和安全性监测指南。

The purpose of the Protocol Review and Monitoring System (PRMS) is to review the scientific merit, scientific priorities, and scientific progress of cancer-related studies that are conducted at the University of Chicago and that use UCCRC resources. The UCCRC PRMS is divided into two committees, the Clinical Trials Review Committee (CTRC), and the Scientific and Accrual Monitoring Committee (SAM), which are overseen by the Associate Director for Clinical Sciences (Dr. Mark Ratain) and the Clinical Research Advisory Committee (CRAC). A single Coordinator serves all three committees. The CTRC and SAM are composed of UCCRC members from all academic units and disciplines who have expertise in clinical trials. The CTRC meets monthly, and has primary responsibility for evaluation of the scientific merit, rigor, appropriateness of data and safety monitoring, and the relative prioritization of trials in the context of UCCRC goals and resources. CTRC and IRB review occur simultaneously, but protocol activation requires full CTRC approval. CTRC reviews are conducted by at least 3 individuals, including a biostatistician. Protocols may be approved, approved with revisions, deferred, or disapproved. Protocols that have undergone prior peer review (e.g., cooperative group protocols, NIH, ACS) are eligible for expedited review; that is, they are not required to be reviewed by the full committee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them to the full committee if there are specific concerns (e.g., design, prioritization). The SAM has primary responsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minority accrual, overall progress towards meeting the study's objectives, as well as ensuring adherence to protocol procedures and UCCRC Data and Safety Monitoring requirements. The SAM meets monthly, and has the authority to close protocols that are not making adequate scientific progress, or that are not meeting adequate scientific or Data and Safety Monitoring guidelines.