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Five Trends Shaping the Trial Master File

The trial master file is integral to demonstrating that a clinical trial has been conducted in accordance with good clinical practice (GCP). The sponsor must therefore ensure their TMF is complete, timely, and accurate at all stages of a trial and across the document lifecycle.

Managing the TMF, however, has often been a challenge for organizations due to resource shortages and document owners not having enough experience with the TMF. Increasingly, artificial intelligence is playing an integral role in improving management and oversight of the TMF, which will have hugely beneficial implications for industry.

Indeed, AI is already shaking up TMF inspection readiness and TMF health in many different ways. As the adoption of AI grows and as the sophistication of AI models expands, several key trends will gain traction as companies seek to ensure they meet compliance requirements with the TMF.

Trend One: TMF Health is Becoming a Greater Priority

Regulatory agencies are becoming more interested in both the TMF itself and the processes around it, and the industry is starting to see more guidelines around how their documents and data are stored.1 They are not only looking at what is in the TMF but also how it gets there, how it’s managed on an ongoing basis and its oversight.

In the past, inspectors focused mostly on ensuring the documentation was in the TMF. However, that led to organizations acting reactively, getting their documentation uploaded and doing a huge push on quality control only when they found out they were having an inspection. That undoubtedly became more and more apparent to the regulators during their inspections and audits, and increasingly they are emphasizing the importance of having the TMF in a good state at all times.

As a result, inspections now look more at the processes and workflows, requiring companies to demonstrate that they are uploading their documents in a timely fashion and that they are keeping track of what needs to be in the TMF.2

AI can help to get companies inspection ready, speed up the preparation process and improve their TMF health, particularly if they are resource-constrained.

Trend two: Digital disruption, including AI, is shaking up the TMF

Having AI solutions focused on the TMF is new to the industry, but there are growing options for using automation and AI to solve different problems. One example is document classification. Using AI to help classify your documents saves time for everyone involved in the TMF and helps document owners who are less familiar with the filing structure.