For Life Sciences organizations, managing an electronic Trial Master File (eTMF) is a critical component of clinical trial operations. The Egnyte eTMF application is designed to help teams manage study milestones, file artifacts, and maintain compliance.
To help your teams—from administrators setting up studies to users managing daily documentation—we have gathered a set of resources covering eTMF configuration, best practices, and daily use.
Egnyte University
-
eTMF App Overview (Admins & Users) This comprehensive course covers the fundamentals of the eTMF app, including creating and importing studies, managing milestones and configuration, uploading documents, and creating reports
-
Uploading Artifacts in eTMF (Users) A quick video demonstrating the process for uploading documents and artifacts into the eTMF
-
Importing Completed Studies to Egnyte's eTMF (Admins) This course details how to import existing trial data from other applications into the Egnyte eTMF using the Exchange Mechanism Standard (EMS)
-
eTMF Study Configuration (Admins). This resource guides administrators through the process of setting up a new study, including defining permissions, milestones, and other key settings
-
eTMF Archival (Admins). Learn the process for properly archiving a completed study within Egnyte to ensure long-term data integrity and compliance.
Egnyte Helpdesk
-
eTMF App (Admins & Users) The central Helpdesk section for the eTMF application. It contains numerous articles on managing milestones, configuring quality control workflows, importing data, and more.
Egnyte.com Resources
-
Clinical Trial Data Management (General Info) An overview of how Egnyte supports the full clinical trial lifecycle, from automated eTMF workflows to secure collaboration and compliance
-
Product Tour for Life Sciences A self-guided tour demonstrating Egnyte's features for Life Sciences, including centralized document control and compliance-ready workflows.
-
Best Practices for eTMF Transfer (Admins) This guide covers the key considerations for a successful eTMF transfer from a CRO to a sponsor, focusing on data integrity, security, and inspection-readiness
-
Blog: Why Your eTMF Vendor Doesn't Want You to Know About the Exchange Mechanism Standard This article explains the importance of the eTMF Exchange Mechanism Standard (EMS) and how it prevents vendor lock-in, ensuring you maintain control of your data.
We hope this collection helps you optimize your clinical trial management. If you have any of your own best practices for managing an eTMF, we invite you to share them below.