DATA COORDINATING UNIT

数据协调股（DCU）设在生物统计学，生物信息学和 MUSC的流行病学将作为本试验的统计和数据协调中心（SDCC）， 数据管理和统计分析。DCU已经建立了一个稳固的基础设施， 数据采集和数据共享，包括指定的网络服务器和支持数据库服务器。方便用户 基于网络的数据库系统已被DCU和临床中心开发、验证和使用 用于在线主题注册，数据输入，数据验证，项目进度监控，用户可定制 报告生成、实验室样本跟踪和安全数据传输。基于Web的数据采集系统 允许通过安全的互联网连接将研究数据直接输入数据库。安全套接字 层（SSL）用于数据加密。该网络系统将所有学习工具整合到一个系统中， 包括研究数据库、在线培训和帮助台、受试者日历、电子数据澄清请求 (OCR)流程、病例报告表（CRF）和参与跟踪系统、稽查跟踪和报告生成 机制等这些报告机制对于研究特定安全性报告以及研究指标非常有用 包括受试者入组报告、数据及时性报告和数据质量报告。本报告所 机制允许授权用户访问已输入系统的实时数据， 验证（通过计算机化的规则检查）。授权用户可以检索注册状态、基本人口统计信息 以及数据总结，例如完成的访视次数、解决的质询次数和未解决的质询次数。 除了受密码保护的研究数据收集网站（WebDCU）外，SDCC和CCC还将 开发一个公众访问信息网站，供社区获取有关参与的信息 网站，新的研究工作在SOD和信息的潜在研究课题。出于安全考虑，本网站 将与WebDCU密码保护的数据收集网站分开。以下各节 简要描述本研究的拟定数据管理计划。

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.