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.
