Protocol Review and Monitoring System

方案审查和监测系统的目标是确保最高的科学质量 和患者安全的个人进行临床癌症研究在UTSW。西蒙斯癌症中心 PRMC由方案审查和监查委员会（PRMC）、数据和安全性监查委员会（PRMC） 委员会（DSMC）和临床研究办公室的行政支持服务共享 资源（CRO）。这三个实体由临床癌症研究委员会（CCRC）监督， 这有助于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，并确定科学的优先事项， 癌症中心的临床问题该委员会由副署长担任主席，并由 临床研究副总监。PRMC审查和监测所有与癌症相关的临床研究 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。PRMC由香港中文大学教授兼主席蔡克博士担任主席。 Radiafion肿瘤学，由Biostafisfics教授Chul Ahn博士共同主持。成员由 癌症中心副主任，并代表必要的专业知识，以提供高水平的临床 肿瘤学方案审查和监测获得委员会批准的方案。所有UTSW临床试验 在IRB安排审查之前，涉及癌症患者的药物必须获得PRMC批准。DSMC 旨在确保癌症相关临床试验的患者安全性和数据质量。DSMC是一个 由癌症中心副主任任命的独立委员会，由大卫博士担任主席 Euhus，临床研究副总监，负责执行数据和安全性 癌症中心的监测计划。首席风险官由林恩贝克女士领导， 临床研究，并负责inifiafing，实施，并进行临床研究方案 在癌症中心。CRO人员包括临床研究协调人员，以及 提供监管和运营支持。

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.