Remote Monitoring Versus Risk-Based Monitoring
Risk-based monitoring and remote monitoring. Many believe that the two words are synonymous and interchangeable. They are not. Here's the difference.
21 July 2015
Remote monitoring and risk-based monitoring. There has been a lot of confusion recently around these two buzzwords.
Many incorrectly believe that the two words are synonymous and interchangeable. They are not.
Watch my video or read the blog below to learn the difference.
Let me first start out by explaining remote monitoring. Remote monitoring describes the subgroup of clinical trials where a clinical research associate (CRA) never physically goes in to the research clinic to conduct their monitoring visits, but reviews the data through secure online workspaces such as Intralinks VIA and other similar platforms. In these types of trials, the research clinics execute the protocol as they would do normally, as well as enter the data on the electronic case report forms (eCRFs). Once this is done, they have an additional step of uploading all of the source documents, labs, medical histories, informed consent forms, and other such documents to the secured virtual workstation which will then become available to the CRA instantaneously and they will receive a notification that this was completed.
Once the documents for a particular visit are in the virtual workspace, the CRA can conduct their “monitoring visit” by comparing the information on the source documents to the information that was entered in the eCRF. Because the monitor completes the source data verification remotely, this monitoring strategy is typically referred to as “remote monitoring”.
It is important to note that the remote monitoring process starts long before the research clinic actually begins to screen and enroll study participants at their site, and it is during this critical site initiation phase, which occurs after a research site has been formally granted the study but prior to the clinic actually screening study participants, where issues can arise. It is during this site initiation process where virtual workspaces can and do provide tremendous benefits to both the Sponsor/contract research organization (CRO) and the research site. Some activities that typically occur during this site initiation process are IRB approval, submission of all necessary regulatory documents and finalizing contracts and budgets. Because of the recent advent of virtual workspaces to the clinical research industry, sites and their CRAs and Sponsors, can collaborate more effectively on finalizing these documents — essentially reducing the time it will take for the research site to begin screening study participants significantly. The site initiation process has always been conducted remotely in the past, but now we have tools such as Intralinks VIA that greatly speed up the process.
Now, I will briefly discuss the complex topic of risk-based monitoring which is a monitoring process that is constantly evolving. You can have a risk-based monitoring study and still have onsite monitoring visits. Alternatively, you can have a risk-based monitoring trial and have remote monitoring visits. The two are not directly or indirectly correlated to one another in any way.
Remote monitoring, as previously discussed, is a monitoring approach within risk-based or non-risk-based monitoring. Remote monitoring does not indicate whether or not the study is a risk-based monitoring study. Risk-based monitoring is something that sponsors and CROs introduced to the industry recently in order to be more proactive when they monitor certain protocols. Rather than wasting a CRA’s time verifying all of the source data, they leave it up to the site to have their own internal quality assurance systems in place (should they ever be audited by the FDA, sponsor, IRB, or other regulatory agencies). CRAs do not need to make sure the data is 100% source data verified under the risk-based monitoring model. It is very expensive and inefficient to send a CRA out once a month to a site and go through mountains of data which is sometimes redundant and compare it to all of the source documents. Under these scenarios, the CRAs are so busy trying to have 100% source data verification, that they often overlook the most critical elements of the study.
In risk-based monitoring, the idea is to more efficiently utilize the CRA’s time, whether they be on site or in a virtual workspace. CROs and sponsors use things such as risk-trend analysis to see which sites are causing a lot of the protocol violations or if there are certain safety issues that are going on with study participants. They look at certain adverse events of interest or certain data points. There are people crunching the numbers in the (electronic data capture) EDC systems to analyze each site as well as all of the sites in aggregate. This way, sponsors can be more proactive in telling the CRAs what they should be paying attention to when they visit a site.
As more data is analyzed during the course of the study, the risk based monitoring strategy may change in order to give more attention to the most critical elements of the study. The idea of risk-based monitoring is to pinpoint parts of the protocols where they anticipate a site to have a lot of problems, adverse events, or protocol deviations. It is a more proactive approach. As more risked-based monitoring studies come out, there are going to be less on-site monitoring visits. That’s where the remote monitoring visits come in, and ultimately, this is the arena where virtual workspaces will serve a very important purpose in allowing the entire workflow of a clinical trial to run as smoothly as possible from the site initiation process to the study closeout.
Dan Sfera is the CEO and President of The Clinical Trials Guru, LLC and DSCS Sweat Equity & Investments, LLC. Through these two companies Dan assists Sponsors and CRO's with Site Selection, Research Staff Training, Recruitment, Contract and Budget Negotiations and Business Development. Dan is also owner, partner and advisor for dozens of clinical research sites across the United States as well as Internationally. With a focus on marketing, finance and operations, he and his team have helped successfully launch many research organizations in the past 10 years.