It can be the professional equivalent of sitting in your dentist’s waiting room the morning of your root canal surgery. Whether it’s unannounced or you received some notice, U.S. Food and Drug Administration (FDA) inspections can be unnerving experiences for clinical trial sponsors, to say the least.
However, there are tools and tactics you can employ to reduce anxiety – and the likelihood of negative consequences, says Brent Sorrells, director of clinical operations at Allakos, a firm developing therapeutic antibodies that selectively target eosinophils and mast cells.
Proactive internal coordination and communication are key, he says. His preparation tips include:
- Coordinate with quality assurance (QA) and regulatory.
- Conduct a mock-inspection or walk-thru.
- Decide what room will host the inspection.
- Designate a “war room” that supports inspection and facilitates offline conversations.
- Determine how the war room will communicate, i.e. Webex, Skype.
- Identify key sites and vendors.
An integral part of your prep work is assigning roles and responsibilities before, during, and after the inspection, Sorrells advises. Assign someone to be the “scribe” with the ability to produce easy to digest transcriptions of conversations and other communications with FDA. Designate a war room and inspection room leader. Identify the appropriate reviewers in the inspection room and the subject matter experts attached to the right documents as needed to share with FDA inspectors.
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections—This eLearning course, free to ACRP Members, takes you through the full life cycle of a regulatory authority GCP inspection and helps you prepare early. Understand when and where inspections are performed, who can be inspected, inspection objectives, and more. View Program Details >>
Finally, it’s obviously important to conduct yourself the right way during an inspection. “Inspectors will make multiple requests in [the] first minute to see how prepared you are,” Sorrells says. It’s critical to give the inspector the impression that you are organized, prepared, and cooperative. “Inspection readiness also helps with due diligence requests that come with less notice,” he adds.
“How you respond sets the tone,” Sorrells says. “Inspection readiness and preparedness reduces chaos and stress.”
Author: Michael Causey