PROTOCOL REVIEW AND MONITORING SYSTEM

议定书审查和监测系统的目的是审查科学价值， 在该大学进行的癌症相关研究的科学优先事项和科学进展 和使用UCCRC资源的公司。UCCRC PRMS分为两个委员会，即 临床试验审查委员会(CTRC)和科学和累积监测委员会(SAM)， 由临床科学副主任(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提供服务。中国红十字会 和SAM由来自所有学术单位和学科的UCCRC成员组成，这些成员 临床试验方面的专业知识。反恐委员会每月开会，主要负责评价 科学价值、数据的严密性、适当性和安全监测，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 协议激活需要获得CTRC的完全批准。CTRC审查至少由3个人进行， 包括一名生物统计学家。协议可以被批准、批准和修订、推迟或 不同意。已经经历过先前同行评审的协议(例如，合作组协议，NIH， 有资格进行快速审查；也就是说，不需要对它们进行全面审查 但将由主席或联合主席进行审查，他们可以选择将其提交给 如果有具体的顾虑(例如，设计、优先顺序)，则由全体委员会进行讨论。SAM有主要的 负责监测CTRC批准的研究的科学进展，包括应计研究、少数研究 在实现研究目标方面取得的总体进展，以及确保遵守 协议程序和UCCRC数据和安全监控要求。SAM每月开会一次， 并有权关闭没有取得足够科学进展的或没有取得足够科学进展的议定书 满足足够的科学或数据和安全监测指南。

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.