Electronic Trial Master File (eTMF); Used to Manage Clinical Trial Documents

 

Electronic trial master file (eTMF) is a method for organizing and storing pharmaceutical documents, images, or digital content; may be necessary for compliance with government organizations. Electronic trial master file stores contents and documents electronically on a cloud or computer server, contains adequate and accurate data, which helps to eliminate the need for organizational framework for filing paper document. Moreover, eTMF shares data with clinical study team members both internally and externally.

A trial master file is a collection of trial documents stored on computers across the world used by attorneys and other attorneys as a reference. A trial master file contains case history, discovery received, case proceedings, opinions, and other associated case information. The file also includes details about the trial date, who conducted the trial, what was decided, who the jury was, and the outcome of the trial. Electronic trial master files (eTMF) can be made available to attorneys using an Internet connection. Almost all organizations involved in clinical trial activity support the compilation of eTMF.

Electronic trial master file (eTMF) is a stored version of a paper trial in electronic format. It is a kind of content management system for both the pharmaceutical and legal industries, offering a more formalized way of managing and organizing case information and creating reference data. Electronic trial master file systems are available online, that allows users to create, store, and access a trial file, and make it accessible via the internet. In some cases, electronic trial master files are accessed directly by the attorneys or their law offices through the use of e-mail or other digital means and web applications.

Electronic trial master file (eTMF) saves time in audit preparation and also reduces time to establish a new clinical site. With the increasing number of clinical trials and rising government funding and grants to support clinical trials, the demand for electronic trial master file (eTMF) is also increasing with a rapid pace. For instance, in July 2020, Zydus Cadila received approval from Mexico's regulatory authority Cofepris to conduct clinical trials with its biological therapy ‘Pegylated Interferon alpha-2b’ for treatment of COVID-19. Mexico has more than 120 ethics committees for the approval of research protocols.