PROTOCOL REVIEW AND MONITORING SYSTEM

项目总结（见说明）：方案审查和监测系统（PRMS）的目的是审查在芝加哥大学进行的癌症相关研究的科学价值、科学优先级和科学进展，无论申办者、部门或类型如何，以及使用芝加哥大学综合癌症中心（UCCCC）资源的研究。UCCCC PRMS分为两个委员会，即临床试验审查委员会（CTRC）和科学和应计监测委员会（SAM），由临床科学副主任（Mark Ratain博士）和临床研究咨询委员会（CRAC）监督。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具有临床试验专业知识的UCCCC成员组成。CTRC每月召开一次会议，主要负责评估数据和安全性监测的科学价值、严谨性、适当性，以及在UCCCC和疾病特异性计划目标和资源背景下试验的相对优先级。CTRC和IRB审查同时进行，但方案激活需要CTRC的完全批准。CTRC审查由至少3人进行，包括生物统计学家。方案可以批准、批准修订、推迟或不批准。已经过同行评审的协议（例如，合作组协议，NIH，ACS）和严格的银行/登记研究有资格进行快速审查;也就是说，它们不需要由整个委员会审查，而是由主席或联合主席审查，如果有具体问题（例如，设计、优先化）。此外，CTRC有权根据SAM委员会的建议关闭协议。具体而言，SAM委员会主要负责监测CTR批准的研究的科学进展，包括应计、少数应计和实现研究目标的总体进展，以及确保遵守方案程序和UCCCC数据和安全性监测要求。SAM委员会每月召开一次会议，并建议关闭未取得充分科学进展或不符合充分科学或数据和安全监测指南的方案。

PROJECT SUMMARY (See instructions): 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, regardless of sponsor, department or type, and that use the University of Chicago Comprehensive Cancer Center (UCCCC) resources. The UCCCC PRMS is divided into two committees, the Clinical Trials Review Committee (CTRC), and the Scientific and Accrual Monitoring (SAM) Committee, 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 UCCCC 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 UCCCC and disease-specific program 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) and strict banking/registry studies 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). In addition, CTRC has the authority to close protocols based on the recommendation of the SAM Committee. Specifically, the SAM Committee has primary responsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minority accrual, and overall progress towards meeting the study's objectives, as well as ensuring adherence to protocol procedures and UCCCC Data and Safety Monitoring requirements. The SAM Committee meets monthly, and recommends closure of protocols that are not making adequate scientific progress, or that are not meeting adequate scientific or Data and Safety Monitoring guidelines.