Sponsors too often make the mistake of accepting one or two years of tenure from potential monitors as an adequate credential, without properly examining tangible skillsets, says Jill Matzat, BSN, RN, CCRT, CCRA, president of Medical Research Management, Inc. In those cases, sponsors “really don’t know what they’re getting,” she notes.
“You’re actually better off looking at people who have the right skill set to [be able to better] train them to be monitors,” Matzat adds. Otherwise, “we’re just shuffling the same people around.”
ACRP has been actively working in concert with other clinical trial industry leaders to shift the hiring emphasis away from “time served” and toward demonstrable skills. “We’ve got to have a way to bring people into the workforce more effectively,” ACRP Executive Director Jim Kremidas wrote in a recent guest column for Outsourcing-Pharma.com.
ACRP and others are working together to develop standards designed to help bring people into the workforce, develop them, and assess them, Kremidas says.
A workforce shortage continues to put pressure on finding and hiring suitable candidates. Unfortunately, candidates don’t always make the search easy. “Half of them probably embellished their resume,” Matzat warns, “because they just want to get that first position.”
Smart Monitoring: Is My Monitoring Adequate? – Join Matzat at ACRP 2018 this April when she will review the use of a standard system and tools to compliment the risk-based monitoring strategy. Learn about effective verification points of consent, deviations, and safety while participating in practice exercises intended to identify, investigate, and resolve real-world site compliance issues. View Session Details
Once hired, that same under-qualified employee won’t “want you to know what they don’t know,” so training and developing monitors is critical, Matzat says. She advocates mentor programs as one way to identify early your potential stars and, perhaps more importantly, weed out recent hires who don’t belong in your organization.
“I’ve had people say to me ‘hey, do you know this person? They claim the worked for you on all these studies,’” Matzat recalls. The reality is a bit different. After a little digging, Matzat may find the employee in question “was with us for 30 days, just as an intern reviewing documents.”
Those kinds of applicants aren’t trained to do the job, Matzat says: “They were trained how to interview.”
The monitoring of a clinical investigation is a regulatory obligation of the sponsor for Investigational New Drug/Investigational Device Exemption studies, and its importance cannot be overstated. Monitoring is a quality control activity and a function of auditing. Inadequate monitoring can directly impact the quality of the trial and jeopardize the safety of study participants.
Author: Michael Causey