Back To The Basics Part 1: What Is An eTMF?
By Gillian Gittens, Director, eClinical Strategy & Solutions, TransPerfect Life Sciences & Sean Momtahen, Product Marketing Operations Specialist, TransPerfect, Trial Interactive
eTMF stands for electronic trial master file. It is the all-important trial master file in a digital format. Over the past decade, it has become standard in the pharmaceutical and biotechnology industries to use an electronic TMF. Global, real-time access, the ability to manage files and document workflows, collaborate, and maintain all essential metadata and audit trails are a few reasons why using a digital format is preferred by many life sciences companies, and also by regulatory agencies. The eTMF has some additional guidelines to ensure compliance. Both the EMA and the FDA have released regulations, policies, and guidelines to follow for validating the use of this electronic format, the most widely followed being CFR 21 Part 11. The overall goal of the eTMF and TMF are the same: to house and maintain all required documentation for a clinical trial. Continue reading to learn why eTMF is important and how it is evolving.
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