TMF 911, What's Your Inspection Readiness Emergency?

A fire. A flood. A heart attack. These are all considered emergencies.

Emergencies take a myriad of forms but share some core characteristics: They are consequential and serious events. They are unexpected and dangerous, requiring immediate action to prevent loss of life, property, or both.

In the life sciences industry, the word “inspection” fits these same criteria. Every TMF inspection, therefore, is a true emergency—but only for the unprepared.

In the last post in this series, we discussed an EMA reflection paper that outlines some of the most common TMF inspection readiness emergencies. We paid special attention to the first item on EMA’s list of common problems found during TMF inspections, “Organisation was unable to provide a full TMF (paper and electronic) for inspection purposes on the request of the GCP inspectors”, and gave real-world advice on how to prevent your own TMF from being found uninspectable.

In this blog post, we will consider another common TMF inspection readiness emergency on EMA’s list. Watch for the next blogs in this series, as we consider the remaining TMF inspection readiness catastrophes on EMA’s list and share more actionable steps for securing TMF inspection readiness.