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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Electronic trial master file ： ウィキペディア英語版 Electronic trial master file An electronic trial master file (eTMF) is 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 term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation. == History and background == In order to comply with government regulatory requirements surrounding BioPharma clinical trials, every organization involved in regulated clinical trials must maintain and store certain 'essential documents' related to the clinical trial to ensure regulatory compliance. Depending on the regulatory jurisdiction, this information is typically stored in the Trial Master File or TMF.〔(ICH Good Clinical Practice January 1997 )〕〔(US FDA Guidance for industry, January 2013 )〕 The TMF has historically been composed primarily of paper documents, images and media captured centrally in physical file cabinets.〔http://www.etmf.org/index.php/resources/〕 In order to lower costs and to expedite the clinical trials approval processes, government agencies involved in regulating clinical trials such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been developing technology initiatives. In the U.S., the FDA created regulation CFR 21 Part 11 which supports the use of electronic records, digital media and digital signatures in clinical trials.〔(US CFR 21 Part 11 April 2012 )〕 In Europe, the European Medicines Agency has issued policies that support the use of digital signatures in clinical trials.〔(EMA eSubmissions December 2008 ).〕 In clinical trials and healthcare, enterprises with manual paper-based systems are seeking to transition to automated electronic enterprise content management (ECM) systems to ensure higher levels of regulatory compliance for reduced business risk.〔(AIIM ECM Report May 2013 )〕 As a result of the FDA's Part 11 policy supporting the use of electronic records and digital signatures in lieu of paper, US organizations involved in U.S. clinical trials can move from a paper-based TMF to an electronic TMF (eTMF), and still be in compliance with FDA regulatory policies. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Electronic trial master file」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.