All pharmaceutical companies have a regulatory requirement to keep eTMF data for the long term – last year’s European Medicines Agency’s (EMA) guidance stipulating storage for over 25 years, is just one example of the growing trend towards changing requirements for long-term management of trial data.
The data needs to be both accessible and readable for regulatory audit purposes. It also needs to be complete and reliable. Data integrity is vital as it should be possible to reconstruct a clinical trial should there be a question about products or trial processes years down the line.
Archiving eTMF data is about much more than just storage and there are plenty of myths, misconceptions, and half-truths on the topic. Below, we look at some of the most common and cut through the myths to find the truth.
1. I can just print my eTMF out – it’s easier to store paper records
Most regulators make it clear that, while physical documents can be digitised with a robust validation process, if a document is ‘born electronic’ it needs to be maintained in this format in the archive.
There may be a desire to print electronic documents for archival, but this isn’t permissible.
2. I have a back-up copy, that will keep them safe!
Maintaining archived eTMF data is not just about securely storing data in a standard backup. It must be checked down to the document level to ensure data integrity. Back-ups are usually conducted on a rolling basis but they don’t detect deterioration in individual files. With a simple back-up, how does an MAH (market authorisation holder) know their documents aren’t corrupted? And if it is, is there an earlier, intact copy available? Are they confident that their eTMF is secure and immutable and that they can access the right versions of documents if and when an auditor requests them?
A robust and ongoing digital archiving strategy and solution is a must – your archiving strategy should involve checking data integrity at the file level on a regular basis.
3. I’ll just leave them in my eTMF system.
eTMF systems are designed for collecting data, ensuring security and facilitating live collaboration, allowing sponsors or CRO partners and trial sites to create versions and update content.
They may not be fit for purpose when it comes to archiving as documents aren’t actively managed, resulting in low data integrity. They also often fall short when it comes to retention periods and data immutability. These could lead to challenges tracking correct iterations and modifications that may have occurred. document tracking and iteration control as well, allowing for modification but, failing to record the changes – which is an essential part of regulatory compliance.
There is also often a need to record data from other other systems or sources and combine them in a secure, immutable environment.
4. I’ll store documents as PDFs, the version will last for the retention period.
While that may meet the needs and standards now, file formats change over time and with innovation. PDFs quickly became the poster-child of safe ‘file’ formats but are increasingly ‘the vehicle of choice for malware and fraud in the cyber landscape’.
There are also problems when it comes to software and version updates – old files may become inaccessible if they are left to go ‘out of date’.
When you consider that the EMA (European Medicines Agency) has mandated retention periods starting at 25 years, anyone archiving eTMF data should question whether PDFs (or any other format) will remain stable and accessible across that time period.
Documents need to be actively managed and processed – it’s much easier to do this on an ongoing basis than in retrospect when an auditor wants to access files stored in an obsolete format.
5. My CRO is better equipped than me to handle the archival.
CROs often lead the way when it comes to innovative trial management and data gathering – but often have the same limitations when it comes to archiving. So, the question to ask is are they maintaining the eTMF as complete and accessible and looking at data integrity and active data preservation? Or, are they just storing it?
Ultimately, archiving eTMF data correctly is the drug sponsor’s responsibility and outsourcing this can create high-risk problems including:
- Cost issues relating to pay per access requirements
- Potentially slow speed of response
- No visibility
Auditors also prefer documents to be consolidated, if a sponsor has multiple CROs and documentation is spread across all of them, this creates barriers during an audit.
The simple truth of eTMF storage
It’s vital that every part involved in the creation, storage, archival and management of eTMF data avoids these pitfalls. Assumptions like those discussed above must make way with a well thought out and holistic approach to long-term eTMF data management supported by dedicated approaches and technology.
Arkivum’s digital archiving software and services make your historical data an asset rather than a risk by removing data silos around your business to make data accessible and usable, guaranteeing 100% data integrity and preserving it for the long term.