Clinical Trials Support Unit

临床试验支持单位（CTSU）的目的是提供中央癌症中心资源， 协调和协助附属医院和门诊的所有癌症相关临床研究 的护理中心。它将促进临床试验相关基础设施的建立和维护， 特别是对于在这方面经验和知识较少的调查人员和机构。受此 机制，它将使和增加临床试验入组到广泛的癌症相关研究。 该股的工作将特别针对少数民族和族裔比例较高的医院和机构， 经济上处于不利地位的患者，为这些患者提供更多参与临床研究的机会， 人口。此外，反恐支助股将促进与外部共同调查员和合作小组的联络， 联邦机构和制药业。 CTSU将为癌症中心的研究人员提供三项主要服务： 1)协助与临床研究和试验相关的监管和行政事务，包括 IRB合规性和批准、持续修订和更新、外部机构合规性（例如 （如FDA），维护监管文件，并协助内部和外部审计; 2)提供研究护理/临床试验管理，特别是对经验不足的研究者 或者那些项目有限的人; 3)提供数据管理和生物信息学专业知识，包括数据库指导， 维护和内部审计。 因此，CTSU将提供高效，具有成本效益的支持，以帮助癌症中心的研究人员进行 科学上有价值的癌症临床试验，并将改善这些试验的可及性，特别是 弱势群体。CTSU的主要办公室位于癌症中心行政办公室内。 贝勒医学院卡伦大楼四楼的办公室。研究卫星办公室 护理/研究协调员位于学院的主要附属临床设施，包括 贝勒门诊护理诊所，圣卢克主教医院，得克萨斯州儿童医院，本陶布 总医院，和迈克尔E。DeBakey VA医疗中心。资源主管是玛莎·米姆斯， 医学博士/博士

The purpose of the Clinical Trials Support Unit (CTSU) is to provide a central Cancer Center resource to coordinate and assist with all cancer-related clinical research within the affiliated hospitals and ambulatory care centers of BCM. It will foster the establishment and maintenance of clinical trial related infrastructure, especially for investigators and institutions with less prior experience and knowledge in this area. By this mechanism, it will enable and increase clinical trial enrollment to a wide spectrum of cancer-related studies. The Unit's efforts will particularly target hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. In addition the CTSU will facilitate liaison with external co-investigators and cooperative groups, federal agencies, and the pharmaceutical industry. The CTSU will provide three major services to Cancer Center investigators: 1) Assistance with regulatory and administrative matters relating to clinical research and trials including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), maintenance of regulatory files, and assistance with internal and external audits; 2) Provision of research nursing/clinical trials management especially to less experienced investigators or those with limited programs; 3) Provision of data management and bioinformatics expertise including database instruction and maintenance and internal audits. The CTSU will thus provide efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and will improve access to these trials, especially for underserved minorities. The main offices of the CTSU are located within the Cancer Center administrative offices on the fourth floor of the Cullen Bldg at Baylor College of Medicine. Satellite offices for Research Nursing/Research Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Ambulatory Care Clinic, St. Luke's Episcopal Hospital, Texas Children's Hospital, the Ben Taub General Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D./Ph.D.