Best Practices for eTMF Standards and Interoperability, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers will discuss best practices for developing your eTMF filing structure and difference between standards, models and what the FDA requires. Attendees will learn how electronic filing structure differs from a paper filing plan and how a metadata-driven approach eliminates the need to create multiple hierarchies.

Xtalks Life Science Webinars

Join Zack Schmidt, CEO of SureClinical and Chet Ensign, Chief Technical Community Steward at OASIS in a live webinar on Thursday, August 13, 2020 at 12pm EDT (5pm BST/UK).

Digital transformation is well underway in clinical trial management as most Sponsors and CROs are moving towards electronic Trial Master Files (eTMF) and other digital solutions to manage their trials. But, there is a learning curve to ensure the most efficiency and power out of an eTMF, and it starts with a good filing structure. This webinar will explore best practices for developing an eTMF filing structure and provide practical advice on best practices to follow when developing one.

In this webinar viewers will learn:

  • Why standards are important to enable eTMF interoperability
  • How standards makes it possible to consistently and seamlessly share data with partners, vendors, Sponsors and CRO’s
  • Difference between standards and models
  • TMF structures and agency requirements
  • How an electronic filing structure differs from a paper filing plan
  • Introduction to eTMF content tagging using standards-based terms based on standards body definitions by NCI, FDA, HL7 and CDISC and others

This is the first of 2 webinars for eTMF best practices and standards (with the second targeted for October). Participants in both series will receive an eTMF Best Practices certificate.

Next webinar:

  • How to classify, structure and tag eTMF content using standards-based terms based on standards body definitions by NCI, FDA, HL7 and CDISC and others.
  • How to use a metadata/tagging-driven approach to simplify the eTMF hierarchy to save time and create powerful search mechanisms
  • Ways to allow organization-specific eTMF tags based on standards
  • Synonyms: If you like ther terms, how to keep them
  • Questions to ask when evaluating an eTMF vendor

For more information or to register for this event, visit Best Practices for Developing Your eTMF Filing Structure.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Sydney Perelmutter
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