Clinical Protocol and Data Management/Clinical Trials Office (Core 015)

临床方案和数据管理（CPDM） 项目摘要 Dan L邓肯癌症中心（DLDCC）的临床方案和数据管理组件 包括临床试验支持部门（CTSU）和数据审查和安全性监查委员会。的 CTSU提供中央管理，研究支持和监督职能，为癌症的行为- 在所有门诊护理中心和医院进行的相关临床试验，是DLDCC的一部分。CTSU服务 所有参与临床研究的DLDCC成员均可使用。CTSU的主要职能是 提供： 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，持续的修订和更新，外部机构合规性（如FDA）， 管理文件的维护， 2)临床试验信息学专业知识，特别是维护癌症相关临床试验的电子数据库 方案、患者登记和临床数据，以及监测和报告累积， 3)质量保证/质量控制稽查和人员培训，以确保研究团队 接受过临床研究最佳实践的培训， 4)研究护理/临床试验管理，尤其是经验不足的研究者。最 2013年1月7日至2014年6月30日，CTSU支持了170项干预性试验，其中包括59项研究者- 启动的研究，其中31项在IND下进行，3项在IDE下进行。 数据审查委员会和安全性监查委员会与临床试验的操作方面是分开的 由CTSU管理，其功能是确保参与者的安全，数据的有效性，以及 在发现不当风险的情况下适当终止研究，或试验似乎 无法成功进行。DLDCC患者安全官员确保所有数据监测 癌症中心试验按照批准的监测计划进行。 相关性 Dan L邓肯癌症中心的临床方案和数据管理组件致力于 提供有效和高效的基础设施，以支持中心的临床研究工作。

Clinical Protocol and Data Management (CPDM) PROJECT SUMMARY The Clinical Protocol and Data Management component of the Dan L Duncan Cancer Center (DLDCC) includes the Clinical Trials Support Unit (CTSU) and the Data Review and Safety Monitoring Committees. The CTSU provides central management, research support and oversight functions for the conduct of cancer- related clinical trials at all ambulatory care centers and hospitals that are part of the DLDCC. CTSU services are available to all members of the DLDCC engaged in clinical research. The major functions of the CTSU are to provide: 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/ Quality Control auditing and personnel training to ensure that the research team is trained in best practices in clinical research, and 4) Research nursing/clinical trials management especially for less experienced investigators. In the most recent year 07/01/2013 – 06/30/2014 the CTSU supported 170 interventional trials including 59 investigator- initiated studies, 31 of which are conducted under IND and three under an IDE. The Data Review and Safety Monitoring Committees are separate from the operational aspect of clinical trials managed by the CTSU and function to ensure the safety of participants, the validity of data, and the appropriate termination of studies in the event that undue risks have been uncovered, or it appears that trials cannot be conducted successfully. The DLDCC patient safety officer ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. Relevance The Clinical Protocol and Data Management component of the Dan L Duncan Cancer Center is committed to providing an effective and efficient infrastructure to support the clinical research efforts of the Center.