EDGE & remote monitoring
during the pandemic
Since the beginning of the pandemic monitoring of clinical trials has become difficult, with many workarounds being found to manage it remotely, whether that is sending redacted source data via email, or holding it up in front of the monitor in a Zoom meeting.
Kim Lee, Felicity Gibbons and Mikayala King from University Hospital Southampton (UHS) raised this with us and together we looked at solutions to use EDGE to solve the challenge and the impacts on privacy, risk and how to mitigate these.
Through a lot of hard work, especially by the UHS team they found a solution that worked with monitors to access the documentation through EDGE as a secure portal. Following this we have recently implemented a new browser PDF function (released this month) to support this process, ensuring that monitors can view the source data on EDGE without downloading it to their work device.
Monitoring in person on site is a costly and time consuming activity, for both site staff and the monitors, with a lot of travel costs involved. Remote monitoring is in its infancy still with regulatory and technological issues to be resolved, however we are working with groups to look at how this can be managed effectively to ensure that both the monitor and staff at site can carry this out in the most efficient way possible.