Inspection Readiness

Answer in the Form of a Complete Sentence

Post by
Denise Lacey
Answer in the Form of a Complete Sentence

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?"

Him:  "Yes."

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:

  • Which SOP, study-specific plan, or other requirement governs that process?
  • When does the process start?
  • What are three high-level steps that summarize the process and who performs them? Include required approvals, if appropriate.
  • How is the process documented?
  • How do you know the process was completed correctly?

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:

  • That process is governed by SOP-XYZ.
  • As soon as the protocol is finalized, the Clinical Study Lead drafts the post, facilitates review by the Medical Monitor and Regulatory Affairs Lead, obtains approval from those people, and then posts the information.
  • The process is documented on the approval form, which is retained in Regulatory Affairs, and in the clinicaltrials.gov receipt, which is downloaded to the TMF.
  • On a quarterly basis, Regulatory Affairs reviews all current studies to verify that initial posts and updates were posted within the required timeframe.

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 herself, but you've just reduced the risk that she 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; she'll probably move on to something else.

It's actually difficult to be that concise:  it requires a lot of practice.