Former FDA Auditor: PIs Primary Target When Agency Comes Calling

Principal Investigators (PIs) need to surround themselves with a good team when a Food and Drug Administration (FDA) inspector comes calling, but they risk serious problems if they forget the buck stops with them. That’s the warning from former auditor that prepared sites for FDA inspections, Chavon Steele, now a senior clinical trial monitor for Medtronic.

PIs seemed ill at-ease and otherwise under prepared at about half of her onsite situations where she audited or prepared for inspections, she says. It’s all the more worrisome given the fact that the PI nearly always knew in advance which study Steele was coming to discuss. Their mistake: “They clearly relied too much on their study coordinators when I’d interview them.” PI’s don’t need to be an expert in minutiae, but they’d better have a demonstrative top-line knowledge of the trial in questions, she emphasizes.

Steele believes the culprit is more often over work or a failure to realize the importance of their role in the inspection rather than an actual need to defend any questionable trial work. That said, an ill-prepared PI made auditor Steele cautious – and that can have a negative effect on the sponsor, too. It could rattle sponsors and jeopardize future job prospects by putting the wrong kind of spotlight on how a site conducts itself. Sponsors “might decide not to use that site in the future if it gets that kind of reputation,” according to Steele.

Internal communications are also a key, she says. One of the first things she’d look for on-site was how well and how often PIs shared information with others. She wasn’t expecting a one-size-fits all approach. She was generally satisfied if she saw evidence of weekly in-person meetings or regular eblasts with pertinent trial updates.

Another audit/inspection focus or concern is around documentation of PI oversight. For example, keep a watchful eye on time lags between when a lab result was available and when the PI signed off. “If it took three weeks it suggested to me there might be some issue” and the FDA inspector needed to investigate. It’s important to tighten those timelines or, if you know you’ve got some gaps, be prepared to explain the reasons to the inspector.