Childhood Adenotonsillectomy Trial

6.6.5 Data Security and Archival at the PRC

The PRC data systems are part of a local area network that is both behind the campus-wide firewall of Case Western Reserve University, as well as protected by the PRC’s own software firewall. Study data will be housed on several existing servers which will have dedicated storage space for this project, with controlled access only to PRC staff involved in this project. Users outside of the PRC (including Clinical Site and DCC staff) will have limited access to designated areas of the FTP server and designated reports through the PRC web site based on individual account information that will be supplied by the PRC. The security of research data during transmittal will be achieved by using an FTPS (FTP over SSL) connection, which will encrypt files during upload. Nightly incremental backups and monthly full backups of data placed on the FTP server and all scored and processed data are made to SDLT tape. Monthly backups are stored in a secure off-site location.