DATA COORDINATING UNIT

数据协调单元

• 批准号: 7426155
• 负责人: VALERIE L DURKALSKI
• 金额: $ 21.27万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7426155
• 关键词: Archives; Bioinformatics; Biometry; Budgets; Calendar; Case Report Form; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Communities; Conduct Clinical Trials; Data; Data Collection; Data Coordinating Center; Data Files; Data Reporting; Data Security; Databases; Electronics; Enrollment; Ensure; Epidemiology; Generations; Gossypium; Housing; Internet; Metric; Monitor; Multicenter Studies; Numbers; Online Systems; Printing; Process; Randomized; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Safety; Secure; Security; Site; Specimen; Study Subject; Superoxide Dismutase; System; Technology; Time; Training; Validation; Visit; Work; computerized; data management; demographics; encryption; experience; programs; quality assurance; tool

The Data Coordination Unit (DCU) housed in the Department of Biostatistics, Bioinformatics and Epidemiology at MUSC will be the Statistical and Data Coordinating Center (SDCC) for this trial and will handle data management and statistical analyses. The DCU has established a steadfast infrastructure for web-based data capture and data sharing, including designated web servers and supporting database servers. Userfriendly web-based database systems have been developed, validated and used by DCU and clinical centers for on-line subject registration, data entry, data validation, project progress monitoring, user customizable report generation, lab specimen tracking, and secure data transfer. The web-based data capturing system allows for study data to be directly entered into the database via a secure internet connection. Secure Socket Layer (SSL) is used for data encryption. The web system combines all study tools into one system which includes study database, online training and help desk, subject calendar, electronic data clarification request (OCR) process, case report form (CRF) and participate tracking system, audit trail, and report generation mechanisms. These reporting mechanisms are useful for study specific safety reports as well as study metrics including subject enrollment reports, data timeliness reports and data quality reports. The reporting mechanism allows authorized users to access real-time data that has been entered into the system and validated (via computerized rule checks). Authorized users can retrieve enrollment status, basic demographics and data summaries such as number of visits completed, number of resolved queries and outstanding queries. In addition to the password protected study data collection website (WebDCU¿), the SDCC and CCC will develop a public access informational website available to the community to obtain information on participating sites, new research efforts in SOD and information for potential study subjects. For security reasons, this site will be separate from the WebDCU¿ password protected data collection website. The following sections describe briefly the proposed data management plan for this study.

在生物统计学，生物信息学和 MUSC的流行病学将是该试验的统计和数据协调中心（SDCC），并将处理 数据管理和统计分析。 DCU已建立了基于Web的坚定基础架构 数据捕获和数据共享，包括指定的Web服务器和支持数据库服务器。方便使用的 DCU和临床中心已经开发，验证和使用了基于Web的数据库系统 用于在线主题注册，数据输入，数据验证，项目进度监视，用户可自定义 报告生成，实验室标本跟踪和安全数据传输。基于Web的数据捕获系统 允许通过安全的Internet连接直接输入研究数据。安全套接字 层（SSL）用于数据加密。 Web系统将所有学习工具结合到一个系统中 包括学习数据库，在线培训和帮助台，主题日历，电子数据澄清请求 （OCR）流程，案例报告表（CRF）和参与跟踪系统，审核跟踪和报告生成 机制。这些报告机制对于研究特定的安全报告和研究指标很有用 包括主题注册报告，数据及时性报告和数据质量报告。报告 机制允许授权用户访问已输入系统的实时数据，并且 经过验证（通过计算机规则检查）。授权用户可以检索注册状态，基本人口统计 以及数据摘要，例如完成的访问次数，已解决的查询数量和未发行的查询。 除了密码受保护的研究数据收集网站（WebDCU¿）外，SDCC和CCC还将 开发社区可用的公共访问信息网站，以获取有关参与的信息 站点，SOD的新研究以及潜在研究对象的信息。出于安全原因，本网站 将与密码保护数据收集网站分开。以下各节 简要描述本研究的拟议数据管理计划。