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A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
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FES (file format) – 3D Topicscape file, produced when a fileless occurrence in 3D Topicscape is exported to Windows. Used to permit round-trip (export Topicscape, change files and folders as desired, re-import them to 3D Topicscape) MGMF – MindGenius Mind Mapping Software file format; MM – FreeMind mind map file (XML)
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