While matters related to how informed consent is obtained at study sites remain at or near the top of most U.S. Food and Drug Administration (FDA) inspectors’ checklists, they’ve also shown an increasing interest in corrective and preventive action (CAPA) programs, says Dr. DeAnn Cary, director of research with Sharp Healthcare in San Diego, Calif.
Cary’s employer has more than 200 trials in process at any given time, she says. Part of her job involves overseeing Sharp’s local institutional review board staff.
Though it isn’t common, FDA inspectors can show up in your waiting room unannounced, Cary says. Typically, however, you’ll have some notice that they plan to come calling. Regardless, it can be a nerve-wracking experience.
“The prospect of a regulatory inspection can be anxiety provoking for sponsors and contract research organizations, and for clinical investigators and their site teams,” notes Terri Hinkley, RN, BScN, MBA, CCRC, deputy executive director of the Association of Clinical Research Professionals.
At Sharp, a community-based health system with seven hospitals and trials running the gamut from neonatal to Alzheimer’s, successful, relatively stress-free FDA inspections are about preparation and keeping the prospect of an inspection in mind every day. It doesn’t have to be an all-consuming fear, of course, Cary stresses.
There are any number of ways to work smart and prepare for an FDA inspection. “There’s no reason you can’t be prepared,” Hinkley says.
For example, Sharp works closely with her team of investigators. Every quarter, six investigators are tapped to write nine-page self-assessments to ensure they are inspection ready at all times.
“It’s not to catch them out as deficient,” Cary says. “It’s a tool to make sure they have what they need.” The exercise gives everyone peace of mind, she adds. “If the FDA comes knocking at the door, we can feel comfortable handing over our regulatory document binder.”
To learn more about CAPA, and preparing for and handling FDA inspections, check out: