The Data Coordination Unit (DCU) housed in the Department of Biostatistics, Bioinformatics andEpidemiology at MUSC will be the Statistical and Data Coordinating Center (SDCC) for this trial and will handledata management and statistical analyses. The DCU has established a steadfast infrastructure for web-baseddata capture and data sharing, including designated web servers and supporting database servers. Userfriendlyweb-based database systems have been developed, validated and used by DCU and clinical centersfor on-line subject registration, data entry, data validation, project progress monitoring, user customizablereport generation, lab specimen tracking, and secure data transfer. The web-based data capturing systemallows for study data to be directly entered into the database via a secure internet connection. Secure SocketLayer (SSL) is used for data encryption. The web system combines all study tools into one system whichincludes 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 generationmechanisms. These reporting mechanisms are useful for study specific safety reports as well as study metricsincluding subject enrollment reports, data timeliness reports and data quality reports. The reportingmechanism allows authorized users to access real-time data that has been entered into the system andvalidated (via computerized rule checks). Authorized users can retrieve enrollment status, basic demographicsand 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 willdevelop a public access informational website available to the community to obtain information on participatingsites, new research efforts in SOD and information for potential study subjects. For security reasons, this sitewill be separate from the WebDCU password protected data collection website. The following sectionsdescribe briefly the proposed data management plan for this study.
