CORE--PROTOCOL AND DATA MANAGEMENT OFFICE

核心——协议和数据管理办公室

• 批准号: 6396723
• 负责人: EVERETT E. VOKES
• 金额: --
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2000-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6396723
• 关键词: behavioral /social science research tag; biomedical facility; cancer registry /resource; clinical research; clinical trial phase I; computer network; health administration; human data; neoplasm /cancer therapy

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.

大学协议和数据管理办公室（PDMO） 芝加哥癌症研究中心 (UCCRC) 是一个共享资源，提供 癌症相关研究的方案和数据管理专业知识 项目。该资源为癌症中心成员提供了基础广泛的 支持他们的临床研究活动。服务有 对于收集必要的高质量数据至关重要 试验成功。自上次提交癌症中心支持以来 格兰特，该设施已被重组，以将生物统计部门分开 协议组件和数据管理组件。办公室有 更名为协议和数据管理办公室。埃弗雷特博士 沃克斯仍然担任该机构的主管。约翰·贝拉尔博士被任命 生物统计设施主任。 方案和数据管理办公室的具体目标是： 1. 促进和协调协议设计、开发和 执行; 2. 促进机构对方案的审查和批准 审查委员会和 UCCRC 临床试验审查委员会 (CTRC)。到 保留与两个委员会的所有通信并确保遵守 符合研究药物使用和毒性的联邦指南 报告； 3. 提供中央患者登记和随机化（当 适用）在所有协议上，并实施有效的程序 接收和存储所收集的数据； 4. 提供质量保证和及时准确的中期报告 根据方案和赞助商的要求积累数据 机构； 5. 开发、操作和维护自动化计算机数据库 网络通信系统将满足科学和 设施的行政需要； 6. 开发并提供设计、内容、 研究数据库的操作和安全； 7. 监控患者的应计情况并确保及时关闭过度或 CTRC 和生物统计学的投入不足的研究 设施，以及 8. 提供数据管理新人员的培训和教育 要求、方案要素和临床试验监测。