Rewind The Clock And Take TMF Back To Basics

By Jacki Petty

Over the past two decades, the Trial Master File (TMF) has undergone a significant evolution, transitioning from traditional paper formats stored in dusty lever arch files to sophisticated electronic systems equipped with placeholders, workflows, and artificial intelligence. The quest for the most advanced electronic TMF (eTMF) is currently in full swing, with technology driving innovation in how clinical trial documentation is managed.

Amidst this technological surge, however, it's crucial not to lose sight of the fundamental principles of the TMF—namely, the 'what' and the 'who'—while being engrossed in the intricacies of the 'how'. As the industry races towards cutting-edge eTMF solutions, there's a risk of overlooking the simplicity and efficiency of the paper-based era, leading to moments of nostalgic reflection where one might quietly admit to a colleague, "It was so much easier when it was paper."

This reminder encourages a balanced perspective, urging stakeholders to appreciate the advancements in technology while valuing the essential foundations of clinical trial documentation.