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eTMF and TMF Inspection Readiness Solutions
Wednesday, July 1, 2020 | 9:59 AM
What is inspection readiness?
Inspection readiness refers to the ability of an organization to operate at a level that allows for effective preparation for an inspection. Per ICH GCP guidelines, a TMF inspection focuses on the documents and records related to the clinical trial versus an audit that encompasses the activities related to the trial (Sec. 1.29, 1.6).
The level to which an organization deems they are inspection ready is somewhat subjective. Generally speaking, the less time it takes to prepare, the more inspection ready you are considered. Real-time inspection readiness refers to maintaining the quality of inspection readiness with no preparation needed. The latter is a more literal definition, and the closer an organization is to real-time, the easier it is for them to be inspection ready.
Inspection readiness is not simply something you do; it is a state of operation. It is optimal good clinical practice and an ongoing organizational discipline.
What problems does being inspection ready solve?
Preparing for a regulatory inspection can feel overwhelming. There is so much to consider, often too little time to do everything needed, and usually not enough people to do the tasks required. Inspection readiness provides ease of mind. We have all seen that spike in queries right before milestone dates. You then scramble to figure out why the system rejected the documents. It could be an issue with submitter training, a coding error, or just an improper filing location. Whatever the challenge may be, elevated queries mean more work and more stress. They happen when you have to work with haste to meet deadlines. Maintaining inspection readiness and using the TMF as an archive allows you to have a smooth and consistent workflow.
Secondly, organizations that maintain inspection readiness have a higher chance of successful inspections without findings. The less time needed to spend preparing for the inspection by catching up on missing documents, the more time available for actual inspection preparation and verification of the TMF filing. You also gain a more constructive workflow through better time management.
What does it mean to have a culture of inspection readiness, and how do you maintain it?
Your team, as well as your organization at large, should have a “holistic” approach and understanding regarding the significance of the TMF. This shared perspective implies that personnel at all levels of the organization are bought-in on its critical importance. In the grand scheme of all clinical trial activities, the TMF can feel like a small part and thus often suffers from competing priorities. An organization cannot achieve the highest levels of inspection readiness without a full, turnkey approach.
There are a handful of processes that must be completed to establish a culture of inspection readiness:
Understanding inspection readiness is more than just knowing its definition. It is about practice, patience, and due diligence. It takes team and organizational buy-in. This culture is inherent to good clinical practice and should be an ongoing organizational discipline. It provides ease of mind and allows you time to tackle the unknown.
Ensure that your organization embraces the critical importance of the TMF to avoid major or critical findings and create space to spend more time on your life-changing research.