How to make sure that an eTMF is compliant to new TMF EMA Guideline?

January 14, 2019

18th December 2018 EMA published a long-awaited “Guideline on the content, management and archiving on the clinical trial master file (paper and/or electronics)”. The release acquired many questions regarding the new reality of TMF, that everyone working in the EU will have to deal with after the document’s effective date 18/06/2019.

How to make sure that an eTMF is compliant to the new TMF EMA Guideline?

Use our checklist(exact quotes from EMA Guideline paper):

  • Electronic TMFs should enable appropriate security and reliability, ensuring that no loss, alteration or corruption of data and documents occur
  • Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution
  • At all times the storage area for the TMF documents (such as paper or electronic media archives and server rooms) should be appropriate to maintain the documents in a manner that they remain complete and legible throughout the trial conduct and the required period of retention and can be made available to the competent authorities of the Member States, upon request
  • The eTMF systems should be validated to demonstrate that the functionality is fit for purpose, with formal procedures in place to manage this process
  • All staff members involved in the conduct of the trial and using the system should receive appropriate training
  • Metadata applied to documents should be formally defined to ensure consistency across all documents
  • The TMF including the audit trail (for eTMF) should be archived appropriately to enable supervision after the clinical trial has ended
  • After archiving any alteration to the content of the trial master file shall be traceable

We’ve recently finished the re-designing process and now our system is not only functional but simply awesome.

Interested? Request a demo via the button on top of the page or drop us an email to bd@flexdatabases.com

Blog

July 1, 2025
What’s New This June: Smarter Imports, Cleaner Reports, and More Flexible APIs

Pre-Validation for CRA Reports The Monitoring Activity report tab now features a validation preview. Users can check for missing fields and review validation messages before generating the final report – enabling more accurate submissions and reducing the need for rework. Bulk Imports for Milestones and Assumptions You can now bulk import project milestones and assumptions […]

June 24, 2025
ICH GCP E6(R3) is about to go live in the EU

The countdown is on – ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared! As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients: […]

June 19, 2025
Checklist: Migrating from a Legacy TMF to an eTMF

Many clinical trial teams still rely on a legacy TMF – whether that means physical binders or outdated digital folders lacking structure and traceability. These systems often fall short in today’s increasingly regulated, fast-paced environment, making oversight and compliance more difficult. That’s why more sponsors and CROs are transitioning to a modern eTMF. A modern […]

We Are Hiring: Scrum Master

📍Remote 💼Full-Time Flex Databases is driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.