With each clinical trial query carrying an estimated $250 price tag, hiring competency-based certified professionals can save sites a lot of money in several ways—including whittling down query frequency, says incoming ACRP Association Board of Trustees (ABoT) Chair Kathryn Kimmel, CCRC, CCRA, ACRP-CP, FACRP, a senior clinical research associate with PRA Health Sciences.
“One of the things that I remind my sites when I’m doing a site initiation visit, is that for every query that’s posted, it costs the site about $250 to answer that query,” Kimmel says. “When you have certified staff, they understand that, and you probably don’t get as many queries posted in the first place.” Getting this done right has many benefits, she adds. “In the long run, it’s a cost savings to not only the sponsor, but the site.”
Those queries can add up fast, too. “It’s not unusual during my first visit to be posting 20 queries per patient, just because they didn’t understand how to use the system,” Kimmel says. The problem compounds itself over the course of a study and, depending on number of patients and study longevity, “that can be a huge chunk of change out of a site’s pocketbook, strictly because they have unqualified staff doing the data entry.”
Promoting certification can also mean improving trial efficiency, Kimmel notes. “Certainly, one would assume that if you have certified staff doing the majority of the work in a clinical study, it’s going to run better,” she says. “It’s going to have less deviations, it’s going to be ready to go to market quicker.”
ACRP Certification Exam Prep at ACRP 2018 – ACRP is hosting three certification exam preparation sessions as part of the Career Growth track at ACRP 2018. Get exam study tips, tricks, and preparation advise from experienced instructors who have already earned the flagship certification in clinical research. Learn More
Site management organizations (SMOs) often pay the price for engaging underqualified staff. Kimmel recounts a situation where an organization that staffed several research facilities had doctors that “just turned everything over to” the SMO. Ultimately, one of the doctors got into trouble with a sponsor because the clinical research coordinator (CRC) the SMO provided him with had “absolutely no clue what she was doing.” Her job before coming on board as a CRC? Trimming trees for a lawn service.
In this instance, the CRC “had absolutely no medical background [and] no business being a CRC,” Kimmel says. However, the site’s principal investigator, who is ultimately responsible for the conduct of a study, had turned the situation over to the SMO. “They put this woman in his clinic and got him in really big trouble, to the point where this pharmaceutical company would no longer work with him…and he didn’t have a clue, but he should have,” Kimmel explains.
Kimmel is looking forward to taking the helm of the ABoT for ACRP in 2018, and she’s got a clear goal. “My platform is going to be about quality and how can we promote quality,” she says. “And I think right at the top of that is certification.”
Author: Michael Causey