Is Your Organization Inspection Prepared?

We hear so much about organizations having an inspection ready TMF at all times; but is an inspection ready TMF truly enough?  An inspection ready TMF is defined as the TMF being of quality and complete based on the milestones of the study.  We achieve this through ongoing review of the TMF at both the document and overall completeness level.  When we look at the completeness of the TMF it is generally based on an expected set of documents relevant to the milestones of the study.  These expectations are built on what we know about the study and what the TMF tells us about the study.  A solid approach to completeness not only confirms that all of the expected documents are there, but also the documents as reflected by study plans and study events (i.e. amendments, updates to Informed Consent Forms, etc).  When we think about being truly inspection prepared, we are confident that we fully understand the story of the study with a confidence that the TMF tells the full story of the study and that the two align.  The key is understanding the story of the study.  A strong sponsor oversight program helps us understand not only the expected events of the study, but the unexpected events.  It is those unexpected events that often create problems for sponsors during an inspection.  Trends in protocol deviations that require additional monitoring oversight activities or training for sites can be the start of conversation about oversight during an inspection.  It may include changing a critical vendor during a study that results in key meetings within the sponsor organization, transition plans, and onboarding of a new vendor.  Smaller organizations often do not have the resources to perform ongoing oversight activities and rely heavily on their CRO partners.  This combined with staff turnover at the sponsor creates an inspection preparation challenge.  When it comes time to prepare for a regulatory inspection, the sponsor is either not aware of many of the events that occurred during the study or realizes that with the departure of key study team members there is a departure of key study knowledge and even more important – documentation.  They find that they are not inspection prepared.  It is important that the sponsor starts at the beginning and identifies gaps in understanding the story of the study, gaps in documentation of that story and inconsistencies between the two.  If you find yourself needing to become Inspection Prepared, Just in Time GCP provides a proven approach to inspection preparation.

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