Understanding the complexities of Remote and Risk-Based Monitoring in a COVID-19 world
By Kathryn E. Vinson, MS, CCRC
At first glance, the terms “Remote Monitoring” and “Risk-Based Monitoring” can bring on anxiety to even the most seasoned professionals in clinical research. Despite the fact that the FDA and the EMA have had guidance posted for researchers on Risk-Based Monitoring (RBM) since at least 2014, the importance of this practice seems to still be regarded with skepticism in the world of clinical research, and many misconceptions about the practice exist. This week, we at DZS would like to take a look at remote monitoring and RBM, and what they can mean for not only CROs but also clinical research sites.
Since the dawning of eCRFs, sponsors have largely had the ability to centrally monitor progress in a trial – issuing queries for data that seems to be out of spec. This is the basis of remote monitoring. It has been around for at least two decades. No reason to worry about that – it is not new. As a coordinator, I loved the ability to resolve queries in almost real-time. I found remote monitoring to be extremely efficient and that it provided for a cleaner trial at closeout. Not only that, when on-site visits did occur, I was able to spend more time with the monitor discussing study issues other than CRF queries.
Risk-based monitoring takes centralized and remote monitoring one step further. RBM starts with a protocol that is written with clearly designated data points that are monitored centrally for deviations. These data points exist not only in the recruitment and screening phases of the study, but also during the conduct phase of the trial. Having these data point “alarms” allow data managers and CRAs to issue queries quickly, while data is still fresh in the mind of a coordinator. There have been many times for me, that it was a simple – oops – typo!
With all this being said, RBM is a process and a fluid process at that. As I mentioned, it begins with a protocol that is written with RBM in mind. Once the protocol is written and approved, project managers, data managers, and CRAs make RBM plans. These clinical research professionals know that plans change and that each site is unique. That is the beauty of RBM – its flexible. A seasoned, proven site with a coordinator that has 20 years of experience will require less hands-on time than a research naïve site. RBM allows a sponsor or CRO to actively monitor for deviations. What if a site records the exact same reason for screening failures on 15 volunteers? Well, that’s a reason to hold an on-site visit. A lab value during the conduct phase of the trial is regularly out of range on a majority of subjects at only one site? Time for an on-site visit.
With RBM, on-site visits can focus more on protocol and SOP education, rather that verification of every data point. CRAs are freed up to get to the bottom of pre-identified issues, and coordinators are more empowered in their data verification duties.
In today’s world of the novel coronavirus, our abilities to remotely monitor data have taken on even greater importance. With many study sites shut down to all but essential personnel, we have little choice but to implement remote monitoring practices (if they were not used before), or to amend existing RBM plans to account for these difficulties.
Centralized monitoring capabilities, such as those available within DZS Insight PlatformTM, with its Protocol Deviation Tracker and Customizable Risk Identification Platform, are essential tools in a world where Risk-Based Monitoring is becoming essential. We invite you to reach out to our team to see how the DZS Insight PlatformTM can help you rein in costs while maximizing the efficiency of your trial team. Most importantly, these practices can help to maintain the safety of your team and trial participants.