Tell Your Study’s Story: Preparing for a Regulatory Inspection

May 6, 2019

Don’t wait for an inspection notice to begin preparations for a regulator’s visit.

Start the trial with a future inspection in mind, says Donna Dorozinsky, founder and CEO of Just in Time GCP. Document all aspects of the trial in the trial master file (TMF) to give an inspector a clear picture of the study. The TMF, Dorozinsky says, is the cornerstone of an inspection.

“If you have a TMF that really tells the story thoroughly and completely, you’re going to have at your disposal all of the information that’s available to allow you to tell the story to the health authority,” she says.

As an example, she cites one trial team that began from the position that their study was at high probability for an inspection. Throughout the study, they assessed operations, making sure the records were complete, deviations were addressed immediately, all the documentation was organized and all the information was easily retrievable. When the inspection came — the end of the story — they were ready to respond to FDA field investigators’ queries.

“They asked, we provided … and as we provided, the questions got answered, and there were no findings for the work we did,” she says.

“Straight up, be honest,” Dorozinsky emphasizes. “If [inspectors] don’t have to go hunting, digging and questioning,” they are less likely to think you are hiding something.

That doesn’t mean that there won’t be a finding or a Form 483 issued, she cautions. But a complete TMF will help explain any problems, how they were corrected, how a reoccurrence will be prevented and how the site will assess any corrective action. Such preparedness really speaks to the FDA, Dorozinsky says.

Eric Pittman, Program Division Director of the FDA’s Office of Bioresearch Monitoring Operations, echoes Dorozinsky in his assessment of site readiness.

“A sign of the lack of preparedness for an inspection is the [organization’s] difficulty in locating records needed,” Pittman says. “The lack of an organized system for records leads to additional questions and ultimately increases the time an investigator is on-site.”

“It is obvious when we start an inspection, almost immediately, if a firm is prepared for us,” says Pittman. “Prepared firms will have a plan for what to do when we arrive, who to call, in general, what to expect.”

Once an inspection is initiated, the TMF should be explained to the inspector, he says. The explanation should include a tour of the documents within the file and what they should/should not expect to find. This is important because that extra few minutes of explanation can significantly reduce the amount of time it takes an investigator to learn the systems.

Trial staff also should be prepared to ask for explanations, Pittman says. “I want industry, in general, to be comfortable asking questions of both the field investigator and FDA management,” he says. “If you don’t understand an investigator’s request, a 483 observation, a discussion point, an action taken by an investigator … it’s perfectly fine to ask.” 


-By John W. Mitchell