(Word count: 455)
Being interviewed during a regulatory authority inspection is nerve-wracking. Suddenly, the tasks you perform every day seem difficult to articulate. It feels awful to be put on the spot, especially for mistakes that were made before you even joined the study team. Here are our favorite "go-to" phrases to help smooth over the rough spots.
That activity is governed by… Whenever you're asked a process question, start your response with this phrase, following it up (of course) with the name of the relevant SOP or project plan. If you need to, carry a cheat sheet for reference. It will give you time to take a breath and will give the impression that your study team's actions are well-grounded in written processes and plans.
Risk-based approach. Sometimes we don't have a well-defined process that describes how we approach a certain task - which vendors we audit vs. qualifying with a questionnaire, for example, or whether we do a 100% quality control review or a lesser amount. In these cases, "We took a risk-based approach" sounds better than "We just made it up as we went along." Of course, the inspector can also suggest that you document your risk-based approach in a written procedure, in which case you can default to…
Thank you for that feedback. When the inspector suggests, critiques, or criticizes, “Thank you for that feedback” is a handy phrase. It stops you from apologizing, justifying, or contradicting the inspector. Even if you don't agree with the inspector's conclusions, it's usually best to let them pass, unless the conclusion is founded on a faulty grasp of the facts. “We'll make a note of that” and “We appreciate your pointing that out” are variations.
The impact was minimal because… Let's say you've just thanked the inspector for their feedback about something that went horribly wrong. After you explain how you responded to a deviation by assessing the root cause, implementing corrective and preventative actions, and doing an effectiveness assessment to demonstrate that the issue did not happen again, you can explain why "the impact was minimal," backing it up with facts from your assessment. A minimal impact may not lessen the severity of a finding, but it's better than a significant impact or not assessing the impact at all.
That activity is documented in… Most responses should end with this phrase, following it up (of course!) with the place where the documentation is filed (typically, the Trial Master File, but sometimes in the Quality Assurance files or captured electronically in a database). This response gives the impression that the quality cycle is being followed, and the inspector will probably ask where documentation resides if you don't volunteer it.
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.