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People who are being trained to participate in regulatory authority inspections are frequently advised, "Only answer the question that's asked. Don't volunteer any other information." This advice leads to exchanges like this one I have at least once a week with my husband:
Me: "Do we need anything from the grocery store?"
Does it answer the question that's asked? Yes. Am I irritated? You bet. Do I have more questions? Yes, including, "Why did I marry a man with this particular sense of humor?"
Certainly, you should not offer up irrelevant information to an inspector, but neither should an inspection interview resemble a verbal tennis match. Inspectors use interviews to determine whether an organization has a robust process in place for following the quality cycle - plan, do, check, improve - and whether personnel understand their role in it. To forestall irritation and further questions, most process questions should be answered in such a way as to give a complete picture of the whole quality cycle:
For example, let's say the inspector asks, "Can you tell me about the process for registering studies on clinicaltrials.gov?" A defensive response might be, "Yes," or "What exactly do you want to know?" Both are guaranteed to irritate the inspector. A complete but concise answer might go like this:
Not mentioned: The fact that the SOP was just approved six months ago, or that the pivotal trial was posted two days late, or that the quarterly review was just instituted last quarter. The inspector is free to dig deeper and discover these things for themselves, but you've just reduced the risk that they will do that by providing a complete, concise answer that shows evidence of the entire quality cycle at work. You haven't thrown up a single red flag; they'll probably move on to something else.
It's actually difficult to be that concise: it requires a lot of practice.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.