TMF inspections have changed quite a bit in recent years. At the basic level, collaboration, preparation, maintenance, and inspection of the TMF is no longer a centralized effort – partly because teams have gone remote and inspections have gone virtual.
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The Trial Master File (TMF) conveys a study’s chronology, and regulatory agencies worldwide view the TMF as a barometer of study health and compliance with Good Clinical Practice (GCP). For this reason, companies undertaking a clinical trial, whether a large or a small clinical study, understand the necessity of agents scrutinizing the Trial Master File, inch by inch, while ensuring compliance. Just as importantly, while the focus of the TMF inspection ultimately drives the method or approach of the review, teams should expect that aspects of it will be conducted virtually from here on out.
Because of today’s disconnected global landscape, remote inspections are challenging. TMFs are often managed in different locations, with content usually spread across other systems. For remote inspections to be successful, they need a single path to compliance; they need TMF management and storage centralization, with one or several interconnected systems that an inspector can access.
While it’s true, the industry, as a whole, is making an undeniable effort to move towards more modern tools for powering their clinical programs. It’s also true that many life sciences companies still support and maintain legacy applications. To secure favorable results in your TMF inspection, sponsors need a more robust and modern eTMF system that supports virtual assessment for the inspectors.
One of the most common reasons Trial Master Files fail during an inspection is a lack of essential records, leaving inspectors unable to reconstruct the narrative of the trial. If teams fail to...
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