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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 content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
Linearized PDF files (also called "optimized" or "web optimized" PDF files) are constructed in a manner that enables them to be read in a Web browser plugin without waiting for the entire file to download, since all objects required for the first page to display are optimally organized at the start of the file. [27]
As with Adobe Acrobat, Nitro PDF Pro's reader is free; but unlike Adobe's free reader, Nitro's free reader allows PDF creation (via a virtual printer driver, or by specifying a filename in the reader's interface, or by drag-'n-drop of a file to Nitro PDF Reader's Windows desktop icon); Ghostscript not needed.
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The Individual Master File (IMF) is the system currently used by the United States Internal Revenue Service (IRS) to store and process tax submissions and used as the main data input to process the IRS's transactions.
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