The COVID-19 pandemic has proven the clinical trial industry can rally quickly to develop vaccines in record time. Remote surveillance of study sites may also have been shown to persist.
“Remote monitoring is not lost,” said Suzanne Sullivan, RN, CCRA, manager of Clinical Research Services at NAMSA. She is responsible for a team of Clinical Research Associates (CRAs) who successfully and quickly transitioned from on-site surveillance to remote surveillance when the pandemic turned clinical trials upside down early last year. “Our team did a phenomenal job. We didn’t drop the ball or lose customers, ”notes Sullivan.
Sullivan and Nicole Tierney, CCRA, BA, a principal CRA at NAMSA, will share observations on how it works and other lessons learned during the ACRP 2021 virtual conference session in May.
Communication and flexibility are obvious components of the secret sauce of success, says Tierney. However, she suggests that planning ahead is at least as important a component as it enables practitioners to be proactive rather than reactive even when something as mammoth as a global pandemic comes into the operational picture.
While everyone is eagerly awaiting the day when COVID-19 will be more of a reminder and less of an obstacle to performing daily tests, Tierney is asking locations to “plan ahead and assume remote monitoring will be involved” from now on a certain way. Even though some studies have returned for on-site surveillance, Tierney notes that the situation could change again immediately. “We have to be ready to use remote monitoring again,” she says, even if it wasn’t in the original curriculum.
Remote monitoring strategies at ACRP 2021 in May
Join Tierney and Sullivan during ACRP 2021 this May to examine how a virtual environment affects clinical trial monitoring and relationships between sites, CROs and sponsors. They share site recruiting strategies to ensure remote monitoring is possible, regulations and guidelines for remote monitoring, implementing new technologies to facilitate remote visits, and more.
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For smaller locations and those with little or no remote experience, that means they are now teaming up with their IT department to set up the technology they need, Tierney says, including a cloud-based file sharing system and setting up remote communication tools such as than Webex and Zoom. “Failing to do this has historically been a problem at some locations where they were not operated by their IT department,” warns Tierney to ensure they can meet the technological needs of using remote monitoring.
In the meantime, Sullivan emphasizes the importance of putting thought and care into developing realistic contracts and budgets. “In many cases, websites are charged more because it takes more time to monitor remotely,” she says. This is especially the case when both sides have not developed clear, understandable guidelines for proper access for subjects to electronic health records (EMRs), she notes. Often the process is not standardized from one location to another, she adds.
“One site might have a simple, one-page confidentiality form to sign to get EMR access, while another might have a complicated, seven-page document that requires multiple signatures,” says Sullivan. “It is very good for everyone if this area is cleared from the beginning.”
Author: Michael Causey