What Is an eTMF? A Beginner’s Guide

Every clinical trial involves documents and data that need to be managed compliantly. One way to accomplish this is by using an eTMF. Here’s everything you need to know.

An electronic trial master file (eTMF) system is the complete electronic library of documents and data that tell the whole trial story from beginning to end. It is the focus of regulatory inspections as it is the source of evidence that the trial was conducted according to protocol and local regulations while following Good Clinical Practice (GCP).

The History of eTMF

Before the digital era, the trial master file (TMF) was kept on paper at a physical location (or, in some cases, many locations). To access the data within the pages, one must find the right shelf, box and folder before accessing the content. This made it difficult for all stakeholders to know what was happening in the trial at a glance.

At the beginning of the electronic trial master file era, eTMF systems were mere tools for digitizing, indexing and displaying records from a paper source. The only way to find necessary data was to go into the eTMF, find the document and then read it through.

As years passed, the eTMF evolved further, with many vendors’ software offering tools to measure Key Performance Indicators (KPIs) such as completeness, quality and timeliness and the integration of optical character recognition (OCR) to make the text within the documents searchable.

How eTMF Is Used Today

In modern times, some organizations still use only a single system for their eTMF, but many organizations have an entire ecosystem of programs, which includes a core eTMF, that read and share data seamlessly with each other for a more complete and real-time picture of trial happenings. Knowledge at your fingertips is invaluable during an inspection. The longer one takes to dig around, the more time the inspector will have to question the robustness of your systems and processes.

Whether implementing a single eTMF system or multiple systems contributing to the whole eTMF, ensuring your processes support the chosen system(s) is crucial.

What Daelight Can Do for Your eTMF

Daelight Solutions can help you during the system selection phase of your eTMF effort by offering an impartial look at each eTMF product in consideration, the features each offers and how your organization can get the most out of the selected system.

Do you already have an eTMF system? Daelight can check your system and processes and provide recommendations for streamlining and improving what you’re doing or helping you prepare to move to a new eTMF solution. It all starts with an eTMF Health Check.


eTMF systems are integral to clinical trials’ seamless management and inspection readiness. Whether an organization opts for a single eTMF system or an interconnected ecosystem of programs, the key to success lies in robust processes that support these digital tools. With the right eTMF setup, stakeholders can gain real-time insights into trial operations, ensuring a transparent and well-documented study.

As an eTMF is crucial to maintaining study records and the integrity of the total trial story, let Daelight Solutions help you make the best decisions about what eTMF system to use and how to use it. Begin by filling out the short questionnaire for our eTMF Health Check.