Regulators are beginning to make greater demands on how data is archived, in conjunction with an increase in the number of systems and eClinical solutions adopted across the data lifecycle.

This is putting pressure on stakeholders to find the right approach to data archiving. How do I ensure that the eTMF and other essential trial records are retained in line with regulations and regulatory guidance, as well as ensuring the effective management of those records over extremely long periods of time.

This is before even taking into account the resources and costs required to achieve this.

These challenges need a new way of thinking. A new approach.

It’s no longer possible to simply leave data where it is or treat it like a piece of paper. To guarantee data is accessible and usable for decades, it must be actively maintained and managed throughout that period.

This guide seeks to provide practical considerations and steps that any organisation responsible for managing GCP records and data can take, to ensure their valuable digital assets are future proofed.

Don't have time to read the whole eBook? Jump to our quick guide to get started below:

In this section we've included the critical info, considerations and approaches to ensure compliant eTMF retention.

Minimum sponsor requirements for TMF retention:

• Most likely looking at a 25-year retention period for the eTMF and essential records - the global nature of trials leads to a highest lowest common denominator in regards to which retention period applies.
• Sponsors must be able to evidence compliance with retention requirements and records must be maintained in an inspection ready form throughout the entire retention period.
• This means that records must be accessible, available and readable on request, for the entire retention period.

How do you ensure the eTMF is accessible, available and readable on request?

• Active Digital Preservation: digital content often outlives the software used to create it - obsolete file formats are unusable and unreadable on future devices. Overcome this challenge by maintaining a long term copy (aligned to digital preservation good practice) of every file in the TMF.
• Data Safeguarding: Satisfying the 'Enduring' principle of ALCOA+ requires sponsors to prove integrity hasn't failed and be able to 'heal' corrupted records. Store eTMF records in multiple geographic locations, automatically check for any integrity issues and have a process in place to replace missing or damaged records with healthy ones.
• Consolidation & Access: Data left in legacy or obsolete systems risks hardware failure or lock-in, resulting in permanently inaccessible data. Consolidating clinical records into a single repository eases long-term management, minimises compliance risks and can reduce costs.
• Inspection Readiness: Slow to retrieve backups or storage are incompatible with today's GCP inspectors, who demand that data is readily accessible and available on request. A centralised archive with managed access controls, supports inspection preparation and improves inspection outcomes.

Download a PDF version of our quick start guide below: