When the US Food and Drug Administration (FDA) calls to inspect your study center, “it’s like a bomb, it’s total chaos,” says Neala Lane, MS, CCRC, associate director of the Quality Improvement Office at Indiana University (IU). She should know; It has had 19 inspections in the past five years.
Don’t expect to always have plenty of time to prepare for an inspection, Lane adds. “We get calls on Thursday saying they’re coming Monday,” she notes.
There are several factors that contribute to the relatively high number of FDA visits to the IU, Lane explains. “We’re a large academic medical center that does a lot of FDA-regulated research,” she says. Plus, the institution has the “lucky” geography of being about a mile from an FDA inspector.
Lane jokes about the lucky geography, but she and her IU team members decided to use it as a motivation to be an even better organization and to share her experiences with other clinical trial practitioners. “We like to share our knowledge and experience in terms of industrial cooperation,” she says.
Lane will share these findings and best practices in a session in the September segment of the ACRP 2021 virtual conference. Among her tips, she says it’s important to have an in-house point of contact that can act as an institutional reminder and help others with the actual inspection.
“It is rarely the same coordinator who is inspected from one FDA visit to the next,” says Lane. As a point of contact, she supports any study coordinator or other practitioner involved in the inspection. “It is comforting for her to know that I am by her side every step of the way,” she adds.
Share Site Secrets: Our Experience with 15+ FDA Inspections
Join Lane on Thursday, September 23, during the third and final tranche of ACRP 2021 to demystify the FDA’s inspection process. By sharing lessons from direct experience with FDA inspections, Lane’s meeting will give the sites the confidence and an organized plan to manage FDA inspections.
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Lane also advises against institutional amnesia after an inspection. “Most sites are so grateful to survive an inspection; they shake off their PTSD and try to focus on other things when they’re over, she notes. While keeping the tests going is important, inspections are also an opportunity to learn how to get better and an opportunity to make the next inspection a lot smoother, she says.
She is also a big advocate of developing a pre, during and post event inspection plan. “Inspections are inherently stressful, but plans and other actions can minimize the burden,” says Lane.
Sometimes it also requires a change in policy on the whole. For example, Lane advocates a culture where mistakes are treated as growth opportunities rather than blame.
“Use mistakes [discovered during an inspection] as a way for everyone to get better, ”she says.
Author: Michael Causey