Food & Drug Regulation

Electronic Trial Master File: Creation, Implementation, and Management

Presented by Antoinette Azevedo
Recorded On: Monday, March 26, 2012
Duration: 90 minutes
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As the world continuously shifts to an electronic world, we are finding that Trial Master Files are following the same path, especially now that trials are conducted all over the world.  While it makes the TMF more accessible and there are numerous benefits, creating and managing an eTMF is not a simple task.  If you are starting the process of converting to an eTMF, have switched recently, or even contemplating making this crucial change, are you prepared to handle the intricate details and challenges of moving your TMF to an eTMF?

Never fear!  Join us for this 90-minute interactive webinar with industry expert Antoinette Azevedo to learn how to not only create an eTMF, but to implement and maintain the new system.  Time will be set aside at the end of the presentation to ask questions.    

Learning Points:

  • What information must be included in a Trial Master File?
    • What data and clinical practices should be included?
  • Strategize how to create an electronic Trial Master File
    • Discuss best practices in implementing and then maintain your eTMF
    • Establish how to handle your TMF during this transition period
  • Study the benefits and challenges the eTMF presents

Who Should Attend:

  • Clinical research managers and associates
  • Compliance officers
  • Regulatory affairs professionals
  • Clinical trial investigators and researchers
  • Training and SOP managers
  • Clinical QA professionals
  • GCP auditors
  • Information technology staff
  • Document control staff



Antoinette Azevedo
Antoinette Azevedo, founder of e-Submissions, advises all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Her clients range from large, international pharmaceutical companies to small, virtual biotechnology companies.