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Southampton develop innovative solution for remote monitoring during coronavirus

The Research and Development (R&D) team at University Hospital Southampton (UHS) has developed an innovative approach to support remote monitoring during the coronavirus pandemic.

Using EDGE, the cloud-based clinical trials management system developed by the Clinical Informatics Research Unit (CIRU) at the University of Southampton, and seen in almost all NHS organisations, the UHS R&D team has developed a new approach which allows sponsors to access trial information remotely.

The innovation has limited the need for sponsors to visit the site in person, which was proving to be a challenge at the start of the pandemic.

Dr Mikayala King, R&D Quality Assurance Manager at UHS and part of the team behind the innovation, explains: “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.”

Mikayala continues: “We were having a conversation one day and I suggested using EDGE. 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.

“Once we started the conversation about EDGE, we knew we would need to validate that process which is a huge job to take on. We would also need to check in with our Information Governance and Information Security teams to ensure that they were happy.”

To take the project forward, Felicity Gibbons and Kim Lee from the Quality Assurance team at the NIHR Southampton Clinical Research Facility (CRF) got in touch with Lee Pearce from CIRU for advice, understanding that it was not a simple task and it was important to risk assess in the first instance.

Kim explained: “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 (CROs) 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.

“We then started looking at what else we could do, for example involving pharmacy and looking at what issues they were having. The whole time Lee from CIRU was helping to answer our questions and move things forward.”

Mikayala added: “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.

“It’s been a lot of work for the team involved but it’s been made easier because we have such a good working relationship with the CIRU team.”

So far, the innovation has been a great success and has resulted in positive feedback from sponsors. Yogeshwari Bhadresa, a Clinical Trial Manager for Bristol Myers Squibb (BMS), said:

“With the first study in BMS to have ‘tested’ the EDGE system for remote monitoring, the Clinical Trial Monitor (CTMo) was very happy with how quickly the requested documents were uploaded into EDGE (none were missing), and how easy it was to find the documents in the system.

“The process went very smoothly and the CTMo was able to complete all monitoring activities as planned. We’d like to say thank you to everyone involved at UHS. Your help in this process is very much appreciated.”

Looking ahead there are plans to further expand the functionality of EDGE in line with the needs of users. Lee Pearce, Knowledge Officer at CIRU, said:

“Felicity and Kim have worked really hard to make EDGE work in the way they need it to and we’re still piloting this with the UHS team at the moment. In the future, we’re hoping to build some extra functionality to further benefit their situation and hopefully help more users.”

To find out more about restarting NIHR research activities which were paused due to coronavirus, please visit the NIHR’s Restart Framework.