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Electronic Trial Master File (eTMF)

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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

Use of a content management system or other electronic repository to store documents of a Trial Master File. According to the non-profit eTMF.org, an effective eTMF system has the following attributes:

  • Machine readable classification scheme – The ability of a computer to read the classification scheme and to use it to create the online electronic TMF repository enables consistency, productivity and interoperability
  • Published, standards-based terms available in machine readable format
  • Automated digital signature capture option to minimize paper handling
  • Automated document audit trail and workflow history
  • Based on web standards – Most ECM systems support XML, HTTP or other web standards to exchange, view and manage eTMF content

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