“I just kept encountering really experienced [clinical research associates (CRAs)] who were having a difficult time making the transition into risk-based monitoring” (RBM). That’s Lysa Triantafillou, director of quality assurance at Rho, reporting from the front lines of clinical trials she’s observed across the country. Yes, RBM is revolutionizing clinical trials with promises of faster speeds, greater efficiencies, and cost savings, but it won’t be fully utilized if the people tasked with using it are befuddled.
In the vast majority of cases, the problem should not be laid at the feet of the CRA, Triantafillou says. “Smart, conscientious, experienced CRAs [are] struggling with the concept and what their roles are going to be like in the paradigm of the future—the RBM paradigm,” she notes.
Triantafillou believes the successful CRA of the (very near) future will end up using RBM to conduct a lot of centralized monitoring and more infrequent visits to the site. It’s going to require a new way to approach the old job, she says, adding that, “I think for the monitor to be successful, those visits are going to have to look a lot like an audit.”
The distinction is important to understand. “As an auditor, we do things a different way,” Triantafillou says. “The traditional monitoring approach is a quality control approach. It’s checking everything.” For auditors, however, “quality control is something that’s backward looking. It’s trying to detect problems that have occurred, whereas quality assurance is forward facing. It’s laying the path for quality [by] putting all of the things in place that are needed to assure compliance.” Broadly speaking, monitors are focused more on preventing errors.
The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance
Join Triantafillou and colleague Susan Leister on November 1 for this live webinar kicking off our “Best of ACRP 2018” series. Learn about the shift in the monitoring paradigm and how to maximize monitoring resources to have the greatest impact on quality and compliance. Hear real-world findings from a well-established audit program in a risk-based monitoring environment, as well as auditor suggestions, to help you avoid common mistakes.
The majority of monitors go in, set up, “and request certain documents, [then] they sit down and they start reviewing the documents,” Triantafillou says. Auditors, on the other hand, begin with questions. “We say, ‘Help me understand how things work around here. Where do your participants come from? What’s your standard record-keeping approach? How is it different for the study, if it is? Are there any records that aren’t standard for this study? How have you accommodated that within your record-keeping practice? Walk me through a typical subject visit to help me, as the auditor, understand what I should expect to see documented.” Auditors take a holistic approach and try to determine if the procedures are adequate at the outset.
It’s a different world for the auditor. Triantafillou says that, when auditors visit a site, they do so for a very limited amount of time. “We typically have two days to conduct a site audit [for Good Clinical Practice],” she notes. “Monitors may go there for two days a month over a lengthy period of time, and yet an auditor can come in for two days, and they can find things that the monitor and site may not have detected.”
Serious findings aren’t common, Triantafillou says, but they aren’t rare, either. “I think the monitors need to take more of an auditing approach—more of a quality assurance [or] forward-thinking approach,” she explains.
Author: Michael Causey