Researchers at University Hospital Southampton NHS Foundation Trust have developed an innovative approach to support remote monitoring, using a clinical trials management system developed at the University of Southampton.
The system, called EDGE, is a cloud-based tool to support clinical research, and has been used by the team at Southampton to allow sponsors to access trial information and be monitored remotely.
Dr Mikayala King, R&D Quality Assurance Manager at UHS, said: “At the beginning of the first lockdown, we suddenly encountered the problem of monitors coming on site. At that time, no visitors were allowed on site, not even those visiting patients, but we still had studies where participants were receiving treatment that needed to be monitored. We needed to come up with a way of doing that remotely.
“We thought about redacting all patient identifiable information and sending a secure email, however we encountered sponsors who required the identifiable notes. We also explored using different software, but that left us with the same problem.
“I knew we could use EDGE to upload information securely and control who has access to it. In fact, we’d used EDGE as a solution before for one of our studies. In this scenario, the sponsor needed demographic information so we provided access to the EDGE record in line with the protocol and ethical approval.”
Kim Lee from the Quality Assurance team at the NIHR Southampton Clinical Research Facility, added: “We didn’t want to introduce the ability to either upload or edit the records. We also didn’t want documents to appear in people’s download history. We solved this by working with one of our sponsors and contract research organisations to work out the process and to come up with a workaround. When the monitor spoke to her IT department, they suggested installing a download blocker which was the first step in allowing us to use EDGE for remote monitoring.
“I think it’s fair to say that EDGE wasn’t designed for this. We’ve taken it and used some of its functionality in a completely different way.
“The team had to go through quite a process finding out what the issues were and then finding workarounds and solutions. Because EDGE was never designed to do this, nobody had ever thought about things like the download blocker for example.”
