A lot of people seem to be confused between risk based monitoring and remote monitoring. So I got interviewed by a magazine the other day, and I was asked to explain the difference between risk based monitoring and remote monitoring because they were using these terms interchangeably. I told them that doing so was not correct because you can have a risk based monitoring study and still have onsite monitoring visits. In fact, most risk based monitoring studies still have onsite visits. So the easiest way to think of this is risk based monitoring is like the whole thing, it’s a concept and remote monitoring is just one part of that concept. So like I said before, you can have a risk based monitoring study and with onsite monitoring visits or without onsite monitoring visits. The remote monitoring part — whether the CRA comes to your site or does not come to your site — does not indicate whether the study is a risk based monitoring study. All remote monitoring means is whether the CRA actually physically comes to your site or whether he or she reviews your data through online databases, eportals, or other electronic platforms that they set up to look at your source data verification, regulatory documents, or startup. On the other hand, risk based monitoring is something that sponsors and CROs came up with to be more proactive when they monitor certain protocols. Rather than wasting their time source data monitoring everything, which they never get around to doing anyway, they leave it more up to the site to have their own internal quality assurance systems in place should they ever get audited by the FDA, the sponsor, the IRB, or any other regulatory agency. So the research clinics are expected to make sure they are a hundred percent source data verified. It’s very expensive for them to send a CRA out once a month to a site, sometimes more than that if it’s a high enrolling site, and just have them go through everything. They’re not able to keep up with all the source and verify a hundred percent of the source data that they’re getting and then match it up with the EDC. So what they do is they use risk trend analyses. They look at areas where sites are causing a lot of protocol deviations, or where there are certain safety issues going on with study participants such as adverse events or serious adverse events. Every time something is entered into EDC there are people on the other side crunching the numbers to try to make some sense out of it, and then being proactive and telling the CRAs what they should focus on. That, in a nutshell, is risk based monitoring. The idea is to look at the parts of a protocol where they anticipate sites to have a lot of problems or where they anticipate a lot of adverse events or protocol deviations to occur. So it’s a much more proactive approach. And yes it’s true, as more risk based monitoring studies come out, you’re going to have less onsite monitoring visits, and that’s where remote monitoring comes and that’s where people usually get confused. They both start with the letter R and they both have the word “monitoring” in them, so that’s probably why people use them synonymously or interchangeably when that is not the case. Yes, risk based monitoring will eventually lead to more remote monitoring. So you’ll have less monitor visits at your site and more remote monitoring visits where you’re using some online tools like Intralinks or some other online platform. Hopefully this helps to clear a bit of the confusion when it comes to the difference between remote monitoring and risk based monitoring .
