Electronic Trial Master File (eTMF)

Use of a content management system or other electronic repository to store documents of a Trial Master File. According to the non-profit, 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