Protocol Review and Monitoring System

议定书审查和监测系统的目标是确保最高的科学质量 以及在UTSW进行临床癌症研究的个人的患者安全。西蒙斯癌症中心 PRMC由议定书审查和监测委员会(PRMC)、数据和安全监测 委员会和临床研究室的管理支持服务共享 资源(CRO)。这三项认证由临床癌症研究委员会(CCRC)监督， 协助副主任监督在癌症中心进行的所有临床研究活动， 向副主任建议新的政策和程序，并确定科学优先事项和 癌症中心的临床问题。中国商业改革委员会主席由副主任担任，联合主席由 临床研究副主任。PRMC审查和监测所有与癌症有关的临床研究 为了科学价值。此外，它还负责监督公开临床试验的科学进展 监控所有SCCC协议的应计费用。筹委会主席为蔡克才教授兼香港大学 Radiafion肿瘤学，由生物统计学教授Chul Ahn博士共同主持。成员由以下人士委任 癌症中心副主任和代表必要的专业知识，以提供高水平的临床 对那些获得委员会批准的肿瘤学方案进行审查和监测。所有UTSW临床试验 涉及癌症患者必须在IRB安排审查之前获得PRMC的批准。Dsmc 旨在确保癌症相关临床试验的安全性和数据质量。DSMC是一种 由癌症中心副主任任命并由David博士担任主席的独立委员会 Euhus，临床研究副主任，负责实施数据和安全 癌症中心的监测计划。CRO由林恩·贝克女士领导，她是 临床研究，负责制定、实施和指导临床研究方案 在癌症中心。CRO的工作人员包括临床研究协调人员以及 提供监管和运营方面的支持。

The goal of the Protocol Review and Monitoring System (PRMS) is to ensure the highest scientific quality and patient safety for individuals going on clinical cancer studies at UTSW. The Simmons Cancer Center PRMC consists of the Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC), and the administrafive support services of the Clinical Research Office Shared Resource (CRO). These three entifies are overseen by the Clinical Cancer Research Committee (CCRC), which aids the Deputy Director in overseeing all clinical research activities conducted at the Cancer Center, recommends new policies and procedures to the Deputy Director, and identifies scienfific priorities and clinical issues in the cancer center. The CCRC is chaired by the Deputy Director, and co-chaired by the Associate Director for Clinical Research. The PRMC reviews and monitors all cancer-related clinical studies for scientific merit. In addition, it is responsible for overseeing the scientific progress of open clinical trials by monitoring accrual to all SCCC protocols. The PRMC is chaired by Dr. Hak Choy, Professor and Chair of Radiafion Oncology, and co-chaired by Dr. Chul Ahn, Professor of Biostafisfics. Members are appointed by the Cancer Center Deputy Director and represent the expertise necessary to provide high-level clinical oncology protocol reviews and monitoring of those which receive committee approval. All UTSW clinical trials involving cancer pafients must receive PRMC approval before the IRB will schedule it for review. The DSMC is designed to ensure pafient safety and data quality for cancer-related clinical trials. The DSMC is an independent committee appointed by the Deputy Director of the Cancer Center and chaired by Dr. David Euhus, Associate Director for Clinical Research, and is responsible for carrying out the data and safety monitoring plan for the Cancer Center. The CRO is headed by Ms. Lynn Baker, Assistant Director for Clinical Research, and is responsible for inifiafing, implemenfing, and conducfing clinical research protocols in the Cancer Center. The CRO staff includes clinical research coordinafing personnel, as well as staff that provide regulatory and operafional support.