Most clinical trials are conducted with onsite monitoring, where a clinical research assistant (CRA) visits the site to perform source data verification, drug accountability, and other review functions. As COVID has imposed significant travel restrictions and stay at home mandates, many CRAs cannot currently perform on-site visits; even if they could, many of their sites have prohibited them from coming onsite to minimize exposure risk.
To maintain oversight during the pandemic, many sponsors and CROs have implemented remote monitoring. In a remote monitoring visit, CRAs review all collected data and documents through secure online workspaces and do not physically visit the site. It is important to note that remote monitoring and risk based monitoring are not the same. Risk-based monitoring is simply the concept that sponsors focus differentially on higher risk areas, such as crucial data points, trendlines and specific triggers (e.g., protocol deviations, adverse events). Risk-based monitoring can be done on site or remotely. Industry experts have advised sponsors to adopt both remote and risk-based monitoring practices during the pandemic.
To understand the current landscape of remote monitoring, Clinical Research IO (CRIO) interviewed research sites to learn what they’re observing, as most sponsors and CROs keep their practices confidential.
Ryan Cady, CEO of Clinvest Research, said
Some of our monitors have started to reach out about remote visits, while others are holding back.
Cady then explained that for those monitors who are conducting remote monitoring visits, his site has had to scan and send documents via email or fax — increasing workload for his site staff.
The CEO of another site said,
The sponsor for one of our largest trials (in terms of enrolled participants) still has us conduct monitoring visits in-clinic. The sponsors that are engaging in remote monitoring are using some combination of email, video conferencing, and telephone calls.
There appear to be many different ways remote monitoring is being implemented. On one end of the spectrum, some CRAs simply do short phone calls to discuss EDC entries and key developments, and do not request access to the source charts; on the other, some CRAs are requesting sites to scan and/or overnight all of the source charts. Many pursue a middle path, requesting only key documents such as delegation and temperature logs, either by having the site scan and send them in, or by having the coordinator hold them for up inspection on a video call. It’s clear that sponsors and CROs have not standardized around a single way of conducting remote monitoring visits.
The large majority of sites that utilize CRIO’s eSource and eRegulatory system report that their CRAs simply log in and perform remote monitoring through the system — a much easier workflow. Clearly, with eSource and other technologies gaining critical mass, remote monitoring is now a much easier proposition for CROs.
In fact, many eSource-enabled sites hope that remote monitoring will become more widely accepted and permanent in clinical research, since it saves both CROs and the sites a lot of time. But will this be the case anytime soon? The short answer, unfortunately, is most likely not.
The site manager of a multi-therapeutic site in New England said that four major CROs have already indicated they plan to resume on-site monitoring, likely in July or August. The manager of a site network based in the South shared that some of their monitors have asked to visit as early as May 15th. Both sites are CRIO eSource clients; in both cases, monitors could have easily performed their monitoring visits remotely if they so chose.
CRIO also heard directly from a clinical trial manager at a major CRO who said, “My whole team will not go anywhere now, but once we can do onsite visits, we will stop anything remote.” He said that remote monitoring is such a huge cultural shift for the organization, and their own SOP’s reserve it for emergency purposes only.
Besides cultural resistance, other reasons cited for a desire to return to on-site monitoring include: desire to adhere to the original monitoring plan; the fact that most sites are still paper-bound and many prohibit source documents from leaving the site; and a belief that on-site monitoring provides relationship-building.
Nonetheless, there are some signs that remote monitoring may become more mainstream in the coming years. One CRO told a site manager that they cited remote monitoring through eSource in their bid defense with their sponsor, and that this was very well received. Another large CRO is considering making an exception for remote monitoring for the duration of the trial for any sites that have adopted eSource. While only anecdotal, these signs may point to the early stages of a mainstreaming of remote monitoring – to the benefit of all.