Why locking your eTMF system post-trial may be putting your data at risk

In the world of clinical trials and pharmaceutical research, the importance of effectively managing Trial Master File (TMF) data cannot be emphasised enough. Many sponsors (and CROs on behalf of sponsors) lock their data into electronic TMF (eTMF) systems and do not consider using a long-term archiving and preservation solution as soon as the study concludes.  While an eTMF system serves as a suitable tool for data archiving during live trials, it is not a post-trial solution for maintaining data in the long term.  

Data Integrity Throughout the Lifetime of your eTMF 

What makes a long-term archiving and preservation solution fit for purpose compared with an eTMF System? The truth is, data faces the risk of corruption or loss over time, which is where sponsors and CROs recognise significant value. A distinct advantage of a long-term archiving and preservation system is that the solution not only verifies eTMF data at the very start when the data is first placed into the archive, it continuously monitors its integrity during long-term storage, ensuring data completeness and preventing corruption. Data that is confined to an eTMF System remains static, untouched, and vulnerable to corruption, this makes it fall short of all ALCOA++ principles, particularly “Enduring”. The major worry here is that if data becomes corrupted, it may stay that way for the entire duration it is confined within an eTMF system, which could span up to 25 or 30 years. A long-term archiving and preservation solution securely stores your eTMF data in at least two locations, this effectively safeguards your data and helps you mitigate risk. Should there be a file that is identified as corrupted, it is simply replaced with a healthy version.  

Technology is Evolving but your Archived Data is not 

Technology evolves rapidly. The tools and systems we relied on 25 years ago are obsolete today, and the ones we use currently may become obsolete in the next 25 years. This presents significant risks to data stored in an eTMF System, where files remain unchanged over time. It’s crucial to ensure confidence that this data can be easily located and accessed using the software and hardware available at any given time. Unfortunately, in this case data stored in an eTMF system may become illegible or inaccessible over time due to technological advancements. Not only does this fail to address ALCOA++ guidelines, but it can present significant challenges during an inspection.  A long-term archiving and preservation solution remains one step ahead, ensuring file formats are fit for purpose for the length of time that the data is needed.  

Commercial Considerations  

When considering regulatory compliance, long-term archiving and preservation solutions offer major advantages over eTMF systems. However, when viewed through a commercial lens, there is also the challenge of Cost Management which becomes even more critical as the number of studies that require long-term archiving increases. It is not only more costly to store your data in an eTMF System for the long-term, but there are also additional costs to move data that has already been locked into the system. A good example of this is during an acquisition or merger where data needs to be migrated for consolidation. Data in a long-term archiving and preservation system is portable, it is quick and easy to move.  

Seize the Opportunity at the End of the Study  

The end of a study presents an ideal opportunity to migrate your eTMF data. During this time, the study team is still engaged, making it easier to coordinate the migration process. Moreover, since the study is fresh in everyone’s minds, there is greater clarity and context surrounding the data, facilitating a smoother transition. 

The longer you wait to migrate your eTMF data to a long-term archiving and preservation solution, the more challenging the process becomes. As time passes, people may move on to other projects or roles, making it harder to gather the necessary expertise and resources for migration. By acting promptly at the end of the study, you can avoid these complications and ensure a seamless transition. 

Final Thoughts 

While there may be a temptation to remain within the confines of an eTMF system, placing your eTMF data in a long-term archiving and preservation solution as early as possible will help reduce risks, manage data integrity and reduce costs effectively.  

Act decisively, migrate responsibly, and reap the rewards of a well-managed eTMF. 

Additional insights on this significant subject are available. On April 16, 2024, Ashley Avery from Cerevel and Antonia Witten from Arkivum co-hosted a webinar titled “Revolutionising eTMF Archiving and Preservation.” Throughout the session, they discussed the significance of TMF Systems in long-term data storage. You can watch the webinar recording via this link.