I always like to share topics that come up in audits that we are performing lately at MVG. A finding that keeps coming up repeatedly in several CRO vendor audits we have conducted is management of the Trial Master File by the CRO. Back in the days of a paper TMF, this was often outsourced to a CRO since they usually had a controlled document room with fire protection and all of the other controls needed to store the TMF safely. A sponsor could not review their TMF without visiting the CRO, something that is now a thing of the past with electronic Trial Master Files.
If given proper access, the sponsor can now review the eTMF in real time when they need access to various documents – at least that is the expectation. We have seen time and time again a CRO not keeping the eTMF up to date with regular uploading of documents in a timely manner. We all know that a TMF should be contemporaneous and as up to date as possible but that is often not the case.
Just like with a paper TMF, sponsors often outsource the management of an eTMF to a CRO due to the cost of an eTMF platform. Each study should have a TMF plan that outlines how the TMF is managed. Between that and the CRO’s SOPs, it should be spelled out how documents are sent to the TMF, who is responsible for uploading, the estimated timeframe for uploading, etc. The plan should also include regular quality checks of the TMF to ensure that all documents are present and filed properly.
Finally, the sponsor should be auditing the TMF to ensure that it is being kept up to date per the TMF plan and that the documentation filed in it is correct and complete. I like to suggest that the TMF be audited about halfway through a study, and again at the end of the study before the TMF is transferred to the Sponsor. Being on top of the management of the TMF throughout your study takes some work, but it is worth it in the long run.
For more about TMF Management and to inquire about an audit of your TMF, please contact MVG Consulting today.
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