In March of 2020, when much of the country began to impose lockdowns and restrictions on public contact due to COVID‑19, I was in New York City on the monitoring trip noted in my previous blog. In the ensuing months, the nature of clinical trial monitoring was mostly redefined in an attempt to continue crucial studies and participant care. The following are some of my observations and lessons learned in the aftermath of that experience.
Every study site I’ve worked with approaches remote access differently. In addition, each has different options for their source documentation. Sites that are able to assign a monitor direct access to their electronic medical records (EMRs) have had the most success. For those sites that typically incorporated “over the shoulder” access to their medical records pre-pandemic, they were faced with the very laborious task of manually uploading each of those records to a separate electronic system. I can’t say if it takes longer to print paper documents and build a shadow chart versus manually uploading them to a separate electronic file, but in either case the records never seem complete. It always seems to result in asking the staff for more documentation at some point. Regularly, I’ve wondered how this impacts study budgets; yet, some sites have no other option but to do it this way. It is one thing to upload a single paper log so that a monitor can see it remotely, but to have to upload every patient visit and test sometimes can take a herculean effort.
For those of us who found ourselves working on COVID-19 clinical research over the summer of 2020 – you know who you are – you found yourself in a race to find a vaccine or better therapeutics for all humankind. Just for the record, I’ve never worked that fast in my career. Everything wasn’t perfect but this was the first time that remote monitoring was more widely adopted as the standard. I was able to receive access to site EMR systems between my scheduled monitoring visits with much more ease than ever before. Having this type of access meant that I could follow study participant visits in real time and answer a sponsor’s question without needing to burden the site staff. Outside of COVID-19 times, I had dreamed of this kind of EMR access. It challenges how monitoring plans will be designed in the future and how much onsite monitoring is truly necessary.
Investigators have taken advantage of technology by incorporating telemedicine visits as a safe way to interact with patients remotely. Hospital staff are offering consultations by phone calls, video chats, emails, and text messages as a substitution for not being in the same room. These virtual interactions need to be documented just like in-person interviews, but that documentation could be located in a separate section of the site’s EMR, depending on the hospital’s processes. Hospitals using electronic informed consent forms before the start of the pandemic were able to take advantage of the benefits and flexibility that come with that. Sites not ready to offer an electronic consent process when the coronavirus impacted our lives were forced to carry on using paper consent forms. Hospitals still needing to work this way were taking completed paper consent forms that had been signed by COVID-positive patients and sealing them off for days until they were considered safe to use.
Electronic documents naturally work best for people with remote access. Research centers already using electronic regulatory binders were poised to move forward with remote visits without as many obstacles. PROMETRIKA was able to offer electronic regulatory binders and secure file sharing platforms to sites that may not have had their own. Paper delegation-of-authority logs had to be replaced by electronic versions when multiple site staff could no longer sign them while in the same space. It isn’t unusual at physical visits to first check in for the day and wait for your contact to bring you the monitoring visit signature log to sign, but recently this has stopped being the first thing that I do at a visit. During a remote visit, I often find myself providing the log by email to the staff, and this usually occurs at the end of the visit.
For a physical visit it isn’t out of the ordinary to have your site contact schedule all of your appointments for you, but a lot of scheduling involved in a remote visit falls on the CRA. During a remote visit, I first need to request the desired days so that my point of contact can help me get access to the center’s EMRs. In addition, I might find myself needing to reach out to the regulatory team, the pharmacy, and possibly a laboratory group to request access to each of their individual platforms. I find myself sending out meeting invitations to the Principal Investigator (PI) so that we can follow up at some point during the visit, and then calling the PI to facilitate those conversations at the appointed time. You could argue that walking to all of those appointments in person isn’t efficient at a large hospital during a traditional visit, but those destinations are always physically there for you if you do. A day in the life of a CRA during COVID involves lots of following up and navigating the systems that each of the pieces use in order to make up for not being physically present. Some of those systems don’t always work as planned, which then becomes the responsibility of the CRA to troubleshoot.
In retrospect, the swine flu pandemic of 10 years ago seems more like a disaster recovery exercise when compared to what we all recently experienced. Although the H1N1 flu came in with a roar, to many it feels like it left with more of a whimper. With the discovery of coronavirus variants like Delta, the current virus continues to demonstrate its staying power.
As we slowly begin to reconnect with colleagues and study site staff in person whenever possible, we are reminded that real presence can add something to our collaborations. What we can accomplish together, in person or remotely, is greater than our individual efforts. Teamwork can unite us in a common goal or create a synergy that brings us together. Some people are missing that unifying thing that makes them feel like they are part of something bigger than themselves. I encourage all of us to continue checking on one another since many are still at home.
A lot of people in the healthcare field are feeling exhausted from the events of the last year. In addition to the greater research community, professions and people from every nation are trying to find a path forward as an alternative to a way back. We must continue to forge a path ahead while making the best of what is available to us now. Please share your experience by replying in the contact section of the PROMETRIKA website.