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，以 在附属医院和门诊内协调和协助所有与癌症相关的临床研究 BCM的护理中心。它将促进建立和维护与临床试验相关的基础设施， 特别是对于这一领域先前经验和知识较少的调查人员和机构。借此 通过这一机制，它将使临床试验的登记人数增加到与癌症相关的广泛研究中。 该股的努力将特别针对少数族裔比例较高的医院和机构， 经济困难患者，为这些患者提供更多参与临床研究的机会 人口。此外，反恐特设局还将促进与外部合作调查员和合作小组的联系， 联邦机构和制药业。 CTSU将向癌症中心的调查人员提供三项主要服务： 1)协助与临床研究和试验有关的管理和行政事项，包括 IRB合规和批准、持续修订和续订、外部机构合规(如 (如FDA)，维护法规文件，并协助进行内部和外部审计； 2)提供研究护理/临床试验管理，特别是对经验较少的研究人员 或那些计划有限的人； 3)提供数据管理和生物信息学专门知识，包括数据库指导和 维护和内部审计。 因此，CTSU将提供高效率、高成本效益的支持，以协助癌症中心的调查人员进行 具有科学价值的癌症临床试验，并将改善获得这些试验的机会，特别是 服务不足的少数族裔。CTSU的主要办公室设在癌症中心行政部门内 贝勒医学院库伦大厦四楼的办公室。卫星研究办公室 护理/研究协调员设在学院的每个主要附属临床设施中，包括 贝勒门诊护理诊所、圣卢克圣公会医院、德克萨斯儿童医院、本·陶布医院 总医院和迈克尔·E·德巴基退伍军人医疗中心。资源负责人是Martha Mims， 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.