CLINICAL TRIALS SUPPORT UNIT

临床试验支持股(CTSU)是协调和报告学院及其附属医院和门诊护理中心内所有与癌症相关的临床研究的中央资源。CTSU促进了与调查人员、合作团体、联邦机构和制药业的联系。在过去的3年里，CTSU特别注重为在这一领域缺乏经验和知识的研究人员和机构建立临床试验基础设施，以便将临床试验登记增加到与癌症相关的广泛研究中。CTSU的目标是医院和 少数族裔和经济困难患者比例较高的机构，为这些人群提供了更多参与临床研究的机会。 CTSU通过四项主要职能全面协调和报告DLDCC中与癌症相关的临床研究：1)协助与临床研究和试验有关的监管和行政事务，包括IRB遵从性和批准、持续的修订和更新、外部机构(如FDA)的遵从性、法规文件的维护；2)临床试验信息学专门知识，特别是维护与癌症相关的临床方案、患者登记和临床数据的电子数据库，以及监测和报告应计费用；3)质量保证审计和人员培训；4) 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。 CTSU提供高效率、高成本效益的支持，帮助癌症中心的研究人员进行具有科学价值的癌症临床试验，并改善获得这些试验的机会，特别是对服务不足的少数族裔。CTSU的主要办公室在贝勒医学院库伦大厦4楼的癌症中心行政办公室，CCGT和儿科CTSU的办公室在费根中心。研究护士/协调员的现场办公室设在学院的每个主要附属临床设施中，包括贝勒诊所、德克萨斯儿童医院、卫理公会医院(成人部分 CCGT计划)、Ben Taub医院和Michael E.DeBakey VA医疗中心。资源负责人是Martha Mims，M.D.，Ph.D.

The Clinical Trials Support Unit (CTSU) is a central resource for coordination and reporting on all cancer related clinical research within the College and its affiliated hospitals and ambulatory care centers. The CTSU facilitates liaison with investigators, cooperative groups, federal agencies, and the pharmaceutical industry. In the past 3 years, the CTSU has particularly focused on establishing clinical trials infrastructure for investigators and institutions with less prior experience and knowledge in this area in order to increase clinical trial enrollment to a wide spectrum of cancer-related studies. The CTSU has targeted hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. The CTSU provides overall coordination of and reporting on cancer relevant clinical studies in the DLDCC via 4 major functions: 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, 2) Clinical trials informatics expertise especially maintaining an electronic database of cancer related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3) Quality assurance auditing and personnel training and 4) Research nursing/clinical trials management especially for less experienced investigators or those with limited programs. The CTSU provides efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and improves access to these trials, especially for underserved minorities. The main offices of the CTSU are in the Cancer Center administrative offices on the 4th floor of the Cullen Bldg at Baylor College of Medicine with CCGT and Pediatric CTSU offices in the Feigin Center. On site offices for Research Nurses/Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Clinic, Texas Children's Hospital, the Methodist Hospital (adult component of the CCGT program), the Ben Taub Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D., Ph.D.