Our infrastructure - security, database input/output
The Casey Reading Center (CRC) is housed within the Casey Eye Institute at Oregon Health and Science University on Marquam Hill in Portland, Oregon.
Data infrastructure and security
The CRC offers interactive and secure web-based software for the management of clinical trials. It is remotely accessible, allowing easy upload of data and image files from clinical sites while allowing real time access for the CRC, sponsors and clinical research organizations. Due to its accessibility, we have taken great pains to ensure the data housed within our database is electronically secured. The reading center software, database and server are FDA compliant for electronic records, according to 21 CFR Part 11, and we follow the FDA guidance put forth on General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The data center and servers are maintained by a specialized team of information technology professionals. Data is backed-up daily and stored off-site. Servers are protected by SSL encryption, ongoing virus and malware surveillance, as well as scanning at the time of upload.
Ongoing and final reports
We provide real-time assessment of data quality for sponsors to access as well as quarterly reports. Flags for poor data are generated for sponsors and for clinical sites and remedial actions are planned if necessary. The CRC provides endpoint exports in XML format. The sponsor can develop an automated import of the XML file for data analysis for timely review at scientific conferences or Data and Safety Monitoring Boards.