eTMF implementation, migration and validation

The Trial Master File is the record that shows how a clinical trial was conducted. It must be complete, organised and inspection-ready, and kept for at least 25 years. Depalop helps sponsors, CROs, research hospitals, universities and clinical sites move to a compliant eTMF, from defining the structure to validation, study close-out and archiving.

TMF structure and configuration

We define the study's document tree starting from the TMF Reference Model and adapting it to your processes: zones, artifacts, metadata, coding, milestones by country, site or laboratory, roles and permissions.

Migration from paper or another eTMF

Inventory of existing documents, mapping to the new structure, import with metadata, sample-based quality control and a reconciliation report, so you know exactly what was transferred.

System validation (CSV)

User requirements, risk assessment, IQ/OQ/PQ testing, traceability matrix and Validation Summary Report, according to GCP, EU Annex 11 and FDA 21 CFR Part 11.

Training and go-live

Role-based training (TMF managers, monitors, site staff), operating procedures for document management and support during the first studies.

Close-out and long-term archiving

Completeness checks at study end, export to formats that stay readable over time and planning for retention across the whole required period.

When a system is needed, we offer eTMFlex, the eTMF developed by Depalop:

• configurable structure through an Excel Data Dictionary, with cross-branch links (symlinks) and automatic coding;
• immutable audit trail and 21 CFR Part 11 compliant electronic signature;
• milestones by country, site or laboratory that generate the document nodes;
• on-premise installation or cloud on European servers;
• free Community Edition for non-profit clinical research and Enterprise Edition for sponsored trials (licensing).

Try the eTMFlex demo or read the project case.

An eTMF has to meet specific rules:

• Regulation (EU) 536/2014 (Art. 58) requires keeping the TMF content for at least 25 years after the end of the trial, on media that keep it complete and legible, with every change traceable and immediate availability to authorities;
• the ICH E6(R3) guideline, effective in the EU since 23 July 2025, expects essential records that are risk-proportionate, identifiable and version-controlled;
• EU Annex 11 and FDA 21 CFR Part 11 set the requirements for computerised systems, audit trails and electronic signatures.

1. Analysis of current TMF processes and ongoing studies.
2. Proposed structure and migration plan, with timelines and responsibilities.
3. Configuration and migration in a test environment, then in production.
4. Validation, training and go-live.
5. Support for the whole study lifecycle, through to archiving.

Can you migrate a paper TMF already in progress?
Yes. We start with a document inventory, map it to the new structure and deliver a reconciliation report between paper and electronic records.

Do you also validate other vendors' eTMFs?
Yes. Our computer system validation service also applies to third-party systems used in GxP contexts.

Can a non-profit organisation use eTMFlex for free?
Yes, with the Community Edition, designed for research institutions, universities and organisations running non-profit studies. Details are on the licensing page.

Where is the data hosted?
In the cloud on European servers, or on your organisation's own servers with an on-premise installation.

Want to move your TMF to a compliant eTMF? Let's talk in a free call.

Contact us