An Inspection Ready versus Inspection Prepared TMF

I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is easy to say we are ready for vacation, but would we be prepared for a vacation if it was offered on short notice?

Being ready and excited for a vacation is so much different than being prepared for a vacation. Preparing to go away on a trip involves many things: packing, arranging for pet boarding/sitting, reservations for a hotel or Airbnb, purchasing plane tickets or planning the road trip and setting up an itinerary. Once we have done the preparations, we are ready to go!

If we think of a Trial Master File Inspection as a vacation (I know, very far-fetched but stick with me on this) – we could say we are ready for a TMF inspection at any day because clinical trial documents are filed in TMF, periodic checks on quality and completeness have been done, we have metrics that measure the health of the TMF, and we have a sense that everything is in order and retrievable.

But are we really prepared for a TMF inspection? Being prepared means that we have done thorough Quality Control and Completeness Reviews throughout the clinical trial to ensure documents are at a high-quality level, that they have been filed accurately, in a timely manner, and are all present. On a deeper level, do we know any Good Clinical Practice issues affecting subject safety and/or data integrity that could be identified in a regulatory inspection? Have we confirmed that they were addressed with CAPAs if needed and did not recur? Do the documents tell the full story of the study? Finally, is everyone who might meet with an inspector ready to tell that story and will the story they tell align with the TMF? When we understand what we were going to do (think clinical trial plans); and that aligns with what we say we did; and that aligns with the story the TMF tells; then we are truly ready for an inspection at a moment’s notice!

If your organization is anticipating a regulatory authority inspection, let Just in Time GCP take the stress out of your inspection readiness activities. We support clients in understanding the story of their study, confirming that their TMF aligns with their story and helping them prepare to speak to that story.  We help organizations make sure their team is prepared for a successful inspection day. We have extensive experience supporting organizations in inspection preparation and the inspection process, our team of subject matter experts are ready to partner with you.


By Joan Given, Inspection Readiness Manager at Just in Time GCP

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