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:

1. Select a diverse group of TMF decision makers

Who will be TMF process owner? The TMF system owner? The functional process owners (FPO)? Once the owners and decision makers are chosen, the next step is to establish a workflow for reporting. There must be accountability for functional owners. The system and TMF owner need to reliably ensure oversight and a reporting schedule. The reporting structure for all TMF owners also needs to be clearly and explicitly established. For example, you may have FPOs in clinical operations, regulatory affairs, and data management. It is natural for one to lose sight of maintaining timeliness in the context of their “day job.” Establishing who is responsible for making sure each FPO is maintaining the targeted level of inspection readiness is crucial. This person is most often the eTMF system owner.

2. Establish a meaningful interaction with the TMF

It is important to establish meaningful interaction with the eTMF (e.g., reports, dashboards, or anything to help show what is or is not in the eTMF). If you are an experienced TMF subject matter expert (SME) you may know how to set up your dashboard to get the best view of your TMF health. However, the majority of TMF teams should seek advice from the eTMF provider on what types of reports and dashboards are essential. Often there are so many different data sets from which to pull reports that it can become overwhelming.

Once you have an idea of how the reporting function works, you can then learn to build your reports. Some useful reports include submissions against queries, published documents rejected, rejection as a percentage of documents, and new submissions.

3. Use the TMF to centralize document archiving

Many functional area owners keep all documents in an area outside the TMF. Then, they upload the required documents as needed. To be in compliance, all of those documents need to end up in the TMF. Using the TMF as an archive creates a standard workflow that allows the documents to start and finish inside the TMF. This makes sure all relevant metadata is available, allows the user to track changes made, and maintains real-time inspection readiness, from author to archive.

4. Perform QA Audits and mock inspections

Mock inspections are valuable in the quest for inspection readiness. They allow for testing and controlling various scenarios, scale, and cost. They push your team and organization toward maintaining inspection readiness. Depending on resources, time, and finances, you can work and create a mock inspection that fits your requirements and helps maintain a culture of inspection readiness. They are also useful tools for showing your organization, team members, and executives the importance of the TMF.
 

Wrap-Up

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 the life-changing research.