PROTOCOL REVIEW AND MONITORING SYSTEM

项目摘要(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、科学优先事项和科学进展，无论其赞助商、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，临床试验审查委员会(CTRC)和科学和累积监测(SAM)委员会，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提供服务。CTRC和SAM由UCCCC成员组成，这些成员来自所有学术单位和学科，他们都拥有临床试验方面的专业知识。CTRC每月开会，主要负责评估科学价值、数据的严谨性、适当性和安全性监测，以及在UCCCC和疾病特定计划目标和资源的背景下确定试验的相对优先级。CTRC和IRB审查同时进行，但协议激活需要CTRC的完全批准。反恐委员会的审查工作至少由3人进行，其中包括一名生物统计学家。方案可以被批准、批准和修订、延期或不批准。经过先前同行审查的议定书(例如，合作小组议定书、国家卫生研究院、美国国家卫生研究院)和严格的银行/登记处研究符合快速审查的条件；也就是说，它们不需要由全体委员会审查，而是由主席或联合主席审查，如果有具体的关切(例如，设计、优先顺序)，主席或联合主席可以选择将其提交全体委员会。此外，反恐委员会有权根据南部非洲联盟委员会的建议关闭议定书。具体地说，SAM委员会主要负责监测CTRC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，并确保遵守议定书程序和UCCCC数据和安全监测要求。SAM委员会每月开会，建议关闭没有取得足够科学进展的议定书，或者没有达到足够的科学或数据和安全监测指南的议定书。

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.