Comply with the EU CTR’s 25-year retention requirement
eTMF Archiving and Long-Term Retention
The end of a clinical trial does not end the responsibility to retain the Trial Master File. Essential records must remain accessible, legible and inspection-ready throughout the required retention period, even after the live eTMF system is no longer needed for day-to-day study management.
Arkivum provides a GxP-validated long-term archive and digital preservation solution for completed eTMFs, helping sponsors move away from operational systems while maintaining control, integrity and access to retained records.
What happens to the eTMF after study close?
Once a study closes, the eTMF moves from an active operational record to a long-term regulatory asset. The sponsor still needs to know that essential records are complete, protected, searchable and available when requested, but it may no longer make commercial or operational sense to keep the original eTMF environment live for decades.
This is where a dedicated long-term archive becomes important. Arkivum separates retention from the live workflow system, giving sponsors a controlled home for the eTMF after the study has finished.
Why a live eTMF system is not automatically a long-term archive
An eTMF system is designed primarily to support the conduct and management of an active clinical trial.
Long-term retention introduces a different set of risks: data corruption, technology changes, file formats become obsolete, systems are retired, suppliers change and access must be maintained many years later.
A purpose-built archive combines retention with safeguarding and digital preservation so the TMF remains usable beyond the lifecycle of the system in which it was originally created.
Retain essential records for 25 years or longer
Arkivum supports sponsors with long-term eTMF retention requirements, including those arising from EU CTR and other applicable regulations and guidance.
The archive is designed to keep retained records accessible and legible while supporting the integrity expectations reflected in ICH E6(R3), ALCOA+ and related GCP requirements.
Rather than treating compliance as a one-off export at study close, the archive provides an environment in which the retained TMF can continue to be managed throughout its lifecycle.
Preserve data integrity and stay inspection-ready
Long-term retention requires more than keeping a static copy. Arkivum applies digital safeguarding and preservation controls to help protect records from corruption, loss and technological obsolescence while maintaining the ability to search and access information when required.
Audit trails, encryption and controlled user access support governance and inspection readiness. Where appropriate, organisations can provide controlled access to relevant users or inspectors without reopening the original eTMF system.
Migrate the eTMF from your CRO or eTMF provider
Arkivum can work directly with CROs and other eClinical providers as part of the migration process, helping organisations move completed-study TMF content into the long-term archive with clear oversight.
The migration service includes quality checks designed to support completeness and accuracy before the records are accepted into the archive, with validation documentation available where required.
Avoid long-term vendor lock-in and unnecessary system costs
Keeping a completed-study eTMF inside an operational platform for the entire retention period can create a long-term dependency on a supplier and a system that is no longer needed for active work. Moving the retained TMF into a vendor-independent archive can support system retirement, reduce complexity and keep the organisation in control of its records.
The archive remains searchable and accessible online, while the original eTMF platform can be managed according to the organisation’s wider technology and supplier strategy.
Why Arkivum for eTMF archiving?
- GxP-validated digital archiving and preservation capability
- Designed specifically for long-term retention rather than live study workflow
- Active preservation to maintain legibility and usability over time
- Searchable, browser-based access to retained TMF records
- Audit trails, encryption and controlled user access
- Validated migration support and direct collaboration with CROs where required
- Alignment with ALCOA+, ICH E6(R3) and applicable retention requirements
- ISO 9001 and ISO 27001 certified organisation
Planning to retire, migrate or consolidate a completed eTMF?
Arkivum’s team was knowledgeable, very helpful and responsive from beginning to end. We are looking forward to working with the team for subsequent eTMF archiving needs.
Neuraly
“We realised that even without an archive, the need to archive data still existed. People simply became creative about where they stored it.”
Jens Norin, Principal Process and Governance Specialist, LEO Pharma
The project was made possible through a unique and seamless collaboration between Galapagos and Arkivum. We had direct access to developers, business process owners and support teams, enabling us to co-create a fit-for-purpose, quality-by-design solution
Kateryna Oliinyk
eTMF archiving FAQs
How long does an eTMF need to be retained for?
Retention requirements depend on the applicable regulatory framework and study context. Arkivum’s current eTMF guidance highlights the 25-year requirement under EU CTR and supports organisations with long-term retention across relevant regulatory environments.
Given the global nature of clinical trials, many sponsors now view the 25-year retention period a the lowest highest common denominator for retention.
Why not leave the TMF in the existing eTMF system?
The operational platform may remain technically capable of holding the data, but long-term retention introduces different requirements around preservation, technology obsolescence, system retirement, accessibility and supplier dependency. A dedicated archive is designed around those long-term risks.
Can Arkivum migrate an eTMF from a CRO?
Yes. Arkivum can work directly with CROs and other providers as part of the migration process and carry out quality checks before records are retained in the archive.
How does the Arkivum solution support inspection readiness?
The archive keeps retained records searchable and accessible online, with audit trails and controlled access helping teams retrieve information and evidence governance when required.
Does Arkivum preserve the eTMF as well as store it?
Yes. Arkivum combines archiving with active digital preservation to address long-term risks such as file-format obsolescence and changing technology.
Can the original eTMF system be retired after migration?
System-retirement decisions remain with the sponsor and depend on its own requirements and validation process. The purpose of moving a completed TMF into a dedicated archive is to reduce long-term dependency on the operational system while keeping retained records controlled and accessible.
