The Trial Master File is the evidence of your entire clinical trial. When your study ends, it is critical that you have a plan to take control of that data without breaking the audit trail.
This whitepaper will cover these key topics, and includes a free checklist to use when evaluating your preparedness!
Regulations around TMF ownership and management
Understanding the CRO-to-Sponsor TMF Transfer Process
Three critical questions to answer when planning your TMF Transfer
TMF Transfer Checklist ✅
Here is a short sample from the whitepaper...to view the complete guide, fill out the form below.
The last deliverable is the lasting deliverable. - Marion Mays
Today, nearly three out of every four clinical trials are outsourced by sponsors to clinical trial organizations (CROs). Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset is the Trial Master File (TMF), defined by the EMA as the collection of essential documents and data records which “enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the protocol, the trial’s safe conduct and the quality of the data obtained.
Given how stringent regulatory authorities are about maintenance of the TMF, even when a clinical trial is outsourced to a CRO, sponsors must show oversight throughout the entire study to ensure regulatory compliance. More importantly, at the end of a trial, sponsors are expected take ownership of the TMF. Most CROs do not take on the responsibility or legal risk for the TMF once a trial closes. Sponsors are faced with one of two choices as a study nears the end, either continue to contract with the CRO to provide ongoing TMF support (if they offer it) or maintain ownership and responsibility of the TMF in-house. The majority of sponsors, particularly small to medium life sciences companies, transfer their TMF into their own system either because their CRO does not offer the service, or because it is cost prohibitive. Planning for the transfer of the TMF from CRO to sponsor is critical.
If you are a sponsor, either currently in a collaboration with a CRO or about to start one, you have to proactively formulate a plan of action for the end of study TMF transfer. It might seem like a straightforward process, but it could easily be riddled with issues that lead to regulatory noncompliance if not planned for and executed . Ultimately, you have to think of the TMF that you receive from the CRO, not as the last deliverable but rather as the lasting deliverable that will ensure the successful inspection of your clinical trial.
The ultimate goal for a sponsor is to end up with an inspection-ready TMF that is properly stored or archived. To that end, there are key things to consider in the planning and execution of the TMF transfer and steps to be taken post-transfer to ensure the quality of the migrated data. This paper will help you understand all the challenges associated with transferring a TMF from a CRO to a sponsor, while highlighting potential pitfalls and offering recommendations to help you successfully navigate this process.
Regulatory agencies worldwide are increasing their scrutiny of the TMF and have provided guidance on what constitutes TMF inspection-readiness. Regulatory authorities are also clear that the responsibility for TMF maintenance and oversight ultimately lies with the sponsor. As per the MHRA...
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