CORE--PROTOCOL AND DATA MANAGEMENT OFFICE

加州大学礼宾和数据管理办公室(PDMO) 芝加哥癌症研究中心(UCCRC)是一个共享资源，提供 癌症相关研究方案和数据管理方面的专业知识 项目。这一资源为癌症中心成员提供了广泛的 支持他们的临床研究活动。这些服务包括 对于收集高质量的数据是必不可少的 审判成功。自上次提交癌症中心支持以来 格兰特，该设施已经重组，以分离生物统计学 组件与协议和数据管理组件。办公室里有 已更名为礼宾和数据管理办公室。埃弗雷特医生 沃克斯仍然是这个设施的负责人。约翰·贝拉尔博士被任命为 生物统计机构的主任。 礼宾和数据管理处的具体目标是： 1.促进和协调协议设计、开发和 实施； 2.便利机构审查和批准议定书 UCCRC临床试验评审委员会(CTRC)。至 维护与这两个委员会的所有通信并确保合规 联邦药物使用和毒性研究指南 报道； 3.规定中央病人登记和随机化(当 适用)，并为以下目的实施有效程序 接收和储存所收集的数据； 4.提供质量保证和及时准确的中期报告 协议和赞助商所要求的累积数据 代理机构； 5.开发、操作和维护自动化计算机数据库，并 网络通信系统将满足科学和 设施的行政需要； 6.开发和提供设计、内容、 研究数据库的操作和安全； 7.监督病人的收入，确保及时关闭超额或 CTRC和生物统计学投入下的应计不足研究 设施，以及 8.为新员工提供数据管理方面的培训和教育 要求、方案要素和临床试验监测。

The Protocol and Data Management Office (PDMO) of the University of Chicago Cancer Research Center (UCCRC) is a shared resource that provides expertise for protocol and data management of cancer-related research projects. This resource provides cancer center members with broad-based support for their clinical research activities. The services are essential for the collection of high quality data necessary for a successful trial. Since the last submission of the Cancer Center Support Grant, the facility has been reorganized to separate the biostatistical component from the protocol and data management component. The office has been renamed as the Protocol and Data Management Office. Dr. Everett Vokes remains director of this facility. Dr. John Bailar was appointed director of the Biostatistics Facility. The specific aims of the Protocol and Data Management Office are: 1. To facilitate and coordinate protocol design, development, and implementation; 2. To facilitate review and approval of the protocol by the Institutional Review Board, and the UCCRC Clinical Trials Review Committee (CTRC). To maintain all correspondence with both committees and assure compliance with federal guidelines for investigational drug use and toxicity reporting; 3. To provide for central patient registration, and randomization (when applicable) on all protocols, and to implement effective procedures for receipt and storage of the data collected; 4. To provide quality assurance and timely and accurate interim reporting of the accumulating data as required by the protocol and the sponsoring agencies; 5. To develop, operate and maintain an automated computer database and network communication system that will satisfy the scientific and administrative needs of the facility; 6. To develop and provide central maintenance for the design, content, operations, and security of the study database; 7. To monitor patient accrual and assure timely closure of over- or under-accruing studies with the input of the CTRC and the Biostatistics Facility, and 8. To provide training and education of new personnel in data management requirements, protocol elements and clinical trials monitoring.