As we adjust to the idea that Covid-19 restrictions will continue well into 2021 we examine how our team are adapting their practices to achieve results whilst remaining compliant. Here we talk to Cassandra Hall, one of our excellent Clinical Research Associates based in the U.S.
It’s February 2020, a day in the life of a Clinical Research Associate starts with taking a plane to the next visit, checking in to a hotel for a few nights before meeting with the Study Co-ordinator, then getting acquainted with the laboratory and study team they will monitor over the next 3 days.
March 2020, lockdown means planes are all but grounded, no in-person contact that isn’t deemed essential and the prospect of everyone having to down tools until we knew more about the highly contagious disease sweeping the globe.
So how do we adapt a service that traditionally relies on floor walking, overseeing other people’s work without interrupting it and interacting with study teams frequently but in a light touch, low overhead manner?
Cassandra explains that most of her role involves being on site to monitor the study, which involves reviewing the study record to ensure compliance with the regulations and protocol, and that patient safety is ensured. Through review of site documentation, she can determine if any discrepancies have occurred on site, and how best to address them with the study team. Being on site, she can walk through the lab and can get a visual of what’s happening, invaluable experience that cannot be replicated through remote monitoring.
Being on site isn’t possible, so what is?
“Certain aspects of study monitoring are easily achieved remotely. Teams on site can scan documentation and provide records to CRAs so we’re able to complete the review electronically, so the core of what we do remotely is not so different from what we do on site.
One critical factor to support this, however, is a secure platform to facilitate the safe sharing of confidential documentation. Patient and study data are highly confidential and need to be handled appropriately. ARC has recently rolled out the use of the Microsoft Cloud platform with Teams and SharePoint, which means we can generate a secure site for each individual study where documentation can be uploaded by the testing site. In remote monitoring, most of the activity occurs in this manner.
During a typical on-site visit, I spend time with the study team to establish a personal connection with the site to help understand their workflows, identify testing pinch-points, and help them work through any issues they have encountered during the study. Since this face-to-face time isn’t possible during remote monitoring, I now personally kick off the engagement with a call with the site investigator and study team and close it off in the same way to help bridge that gap.”
What would you say has been the biggest impact?
“The most obvious and unavoidable impact is the fact we cannot walk through the lab and have that face-to-face contact, which can never be fully replicated remotely. However, at ARC we work hard to build relationships with our labs and maintain connections with our study teams, so communication becomes easier. We’re familiar with the sites and the people involved so we can get in touch with the appropriate person to dig into something that doesn’t seem quite right. It also means that the teams are encouraged to reach out and ask any questions.
The second main impact of remote versus in-person monitoring is time. Locked in a room at the site for a day with the study binder, I have access to all the documentation I need. If anything is missing, I have direct access to the study coordinator or other staff for help, whether asking questions about testing, or signatures on a document. In the remote monitoring environment, we are relying on a Study Co-ordinator to replicate the study record electronically, which can be extremely time consuming on their end: we ask that they scan and upload essential documents and testing records, which is usually a minimum of 50 or so pages and can easily become hundreds. Once documents are available for us to review, the magic that is monitoring can happen! During our review, we make notes of queries and findings for discussion with our sites’ personnel which overall, is much more time consuming than the physical review. Despite the tedium that this seems to present, there is an upside! Studies often require document reconciliation between site and sponsor records, and the level and detail of documentation shared in this way means we can eliminate a separate activity for the site. Got to take the positives when we can!”
What workarounds did you discover in adapting to these challenges?
“As an example, in the early days of COVID-19, we had challenges getting wet signatures following a site initiation visit. The Study Co-ordinator and Investigator, if they were not an essential lab worker, were all working remotely; everyone had different office set ups, some couldn’t print, others didn’t have a secure document signature programme. We had to get creative.
Collaborating with our Pharmaceutical partner, we decided that in lieu of a wet signature to confirm their training record, the individuals had to enter their name and date by email and state that this was representative of their wet signature. They would then countersign the document with a wet signature when it was possible to get back into the office. This may seem like a relatively innocuous problem, but it had the potential to put the brakes on activating a site.
Navigating challenges, such as a sudden global shift to remote monitoring, is easy to manage when you have a group of really experienced individuals who know how to assess risks and think ahead about the impact of decisions in order to keep moving forward while still maintaining compliance and patient safety.”
“Typically, when I’m on site I complete my report as I go, as I have a limited amount of time to spend with the study records. Doing things remotely, one huge benefit is having access to electronic records after the visit so it’s easy to look back and quickly check the detail in a particular scenario. I’m able to make use of different applications to maximise review tracking and capture more comprehensive notes., which means that my output is much more detailed.”
Do you see any of these changes as being a disruptor to the industry overall?
“The biggest change I see is that, historically, a CRA’s purpose – to monitor study conduct and ensure patient safety – is achieved through travelling to be on-site for monitoring. Given the limitations we’ve had to work within as a result of the pandemic, there seems to be a global shift in perspective within our field about what can be achieved remotely versus being on site. There are cost savings and efficiencies: no airline or hotel fees, and less CRA hours lost to an airport commute or bad internet on the plane. It’s easier for the site, as they don’t have to take time to supervise me as a visitor, chaperone me to the restroom or lunch. However, it’s only valuable if we can do as good a job remotely as we can on site. I think the ARC team is more than capable of this as we have the expertise, and we know how to pivot when we face challenges around monitoring. That said, there will always be some things you just can’t replicate remotely.
On a personal note, the benefits are more time at home with family which is fantastic. From an operational efficiency perspective, I can now deliver two visits in a week and give each of them more dedicated, productive time. Less typing up of reports on a tiny screen when getting from A to B and more time and energy to channel into the final deliverable.”
There are many pros and cons and thankfully we have been able to keep delivering an excellent service without breaking stride, but part of our strength is our relationship with our clients and partners, and we look forward to further refining our remote monitoring approach, in conjunction with resuming in-person visits in future.