Five Phrases to Avoid in Inspection Interviews

Regulatory authority inspectors interview personnel to get information about the study and to verify that the study team has a quality mindset. Toward that end, here are five phrases to avoid during inspection interviews, with alternatives to use in their place.

I don’t remember. No one expects you to remember everything, but a better response is, “I will get back to you with a detailed response.” Note that this is a perfectly valid response when being asked a detailed question, such as, “What was the date of the site initiation visit for the first US site?” However, if the question a general one in your area of expertise, such as “How are site monitors trained to fulfill their job role?” you should be prepared with an answer.

I wasn’t here at the time. The inspector is there to learn about the study – not to learn about your personal experience with the study. At best, this detail is irrelevant; at worst, it suggests that you haven’t done the necessary work to prepare for this inspection. If you have no idea how to answer the question, tell the inspector, “We’ll look into that and get back to you.” If you know the answer, give it. If your start date is relevant to the answer, you can add, “I started on the study on…” but don’t use it as a reason for not answering the question.

It wasn’t that big a deal. This response is sometimes deployed to minimize a quality issue. It may cause an inspector’s hackles to rise – a deviation is a big deal, even if the impact is negligible. Make the same point with less inflammatory language: “The impact on patient safety was low, because…”

I’m sorry. This is an inspection, not a performance review. “Thank you for your feedback” is a useful alternative.

The CRO (or investigator/site coordinator/previous study team lead) was terrible. Throwing your team members under the bus is not just a bad look; it highlights the weaknesses of your quality system, which is supposed to have appropriate checks and balances to withstand one error-prone team member. Again, “Thank you for your feedback” covers a multitude of sins.