The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.
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Take Advantage of Your System’s Features
Whether you choose Medidata eTMF, Veeva Vault, or one of the countless other eTMF systems out there, your system will have features designed to make eTMF maintenance easier: use them!
The PROMETRIKA Way: The Medidata eTMF, for example, has a variety of pre-programmed reports that can be altered and customized to best suit the needs of your study. Some of the reports that our team at PROMETRIKA uses regularly include a rejected document report, which shows all documents that have been rejected within a specified folder and why, and a “properties search,” which allows users to filter reports by properties such as the document date, artifact, zone, level, file type, and so much more. A few of the ways we use the properties search include generating reports that show all the expected documents for a certain study milestone, or all the documents filed to a certain functional area. Additionally, there is the option to “tag” documents with different customizable labels, allowing easy organization. Studies that utilize an integrated eTMF and Clinical Trial Management System (CTMS) have additional features such as automatic filing of visit letters and reports from the CTMS into the eTMF, helping prevent missing documents and saving time for the eTMF Specialist.
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Regular Review of Expired Documents
Picture this: an auditor asks you for the Principal Investigator’s medical license from one of your study sites. You go to your TMF to retrieve the document but soon realize it expired months ago and has not been replaced. This predicament could easily be avoided through regular, proactive monitoring of expired documents. Here at PROMETRIKA, our rule of thumb is to review the TMF for overdue and upcoming expiration dates on a monthly basis. This method, which involves noting documents approaching their expiration dates in addition to already expired documents, allows the eTMF Specialist to proactively solicit documents from sites or study stakeholders, before they expire. This way, you will never find yourself blindsided with expired licenses, trainings, or certifications!
The PROMETRIKA Way: At PROMETRIKA, we use the Medidata eTMF, which allows users to run reports for both expired documents and documents expected to expire within a given number of days. Once an expired document is replaced, we use the previously mentioned “tagging” feature to mark a document as replaced to prevent duplicative efforts in the future.
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Upfront Planning and Regular Check-Ins with Study Team Members
The eTMF is unique in the way it requires contribution from all members of the study team, not just those in clinical operations. While those who work in the eTMF regularly have established an understanding of its ins and outs, the eTMF can be intimidating to many study team members. Working with study team members at the beginning of a project to establish expectations and provide training and education around the eTMF can help set up everyone for success. Furthermore, regular check-ins with such team members can ease anxiety around the eTMF as it allows for problems and shortcomings to be identified and corrected early. Instead of waiting until right before an audit and scrambling to collect documents, which will undoubtedly overwhelm all parties involved, make it a habit to have some kind of regular communication where you can work with your team to identify documents that are ready to be added to the TMF.
The PROMETRIKA Way: At PROMETRIKA, the eTMF Specialist sends monthly reports to the project team and additional pre-visit preparation reports to CRAs prior to upcoming monitoring visits. eTMFs usually have tools that allow us to customize reports that show documents and placeholders for each functional area, such as Data Management and Safety. Working with all members of the study team and providing them with the support they need to, in turn, support the eTMF is an integral part of TMF management; at the end of the day, you cannot have a complete and accurate eTMF without everyone’s contributions.
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Consistency is Key
There are few things that can make a TMF appear disorganized and poorly planned quite like inconsistent naming and dating of documents. Therefore, it is crucial to establish document naming and dating conventions. For example, will you include visit numbers in the document name of monitoring visit reports? If a document was completed on one date, but signed on a later date, which will you use when dating the document? Having an established system will not only save time while filing, but it will make finding documents much easier down the line.
The PROMETRIKA Way: At PROMETRIKA, we have an agreed upon naming and dating conventions document that allows for consistency, not only within studies but across all of the studies we support.
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Formal Periodic Quality Checks
Although daily maintenance is crucial for an audit-ready eTMF, every eTMF can benefit from a formal, well-documented, periodic QC. You might be wondering why a periodic QC is necessary if you follow the steps outlined above, but remember that even a person who brushes and flosses everyday should still go to the dentist twice a year for a cleaning. The “deep cleaning” that you can get from a periodic QC cannot be replaced, and it also serves as a great way to check in on the health of your eTMF.
The PROMETRIKA Way: Our periodic eTMF QC process at PROMETRIKA involves examining already filed TMF documents for quality, checking timeliness metrics, and reviewing the expected number of documents versus the actual number of documents in the eTMF to identify anything that might be missing. This process not only keeps our eTMF inspection-ready, but it provides metrics that can identify potential areas for improvement in our processes and operations.
With these five steps in practice, it would be hard not to have an inspection-ready eTMF. The combination of strategic regular maintenance and thorough periodic reviews ensures that no detail is missed and virtually guarantees a complete, accurate TMF. It is never too late to start regular eTMF maintenance, and if you follow these guidelines, you can have any TMF inspection-ready in no time!
