Using an eTMF solution is an effective way to manage data during a clinical trial. But upon completion, using the solution as a means of archiving the eTMF presents several challenges which could put your data at risk.
In this blog post, we will explore some of the main risks associated with using an eTMF solution as a means for archiving data post clinical trial. We will also share some alternative solutions that we believe are much more viable and align more closely with the GCP guidelines.
What is an eTMF solution? (And why is it so important?)
As many of you will know, the Trial Master File (or TMF) contains all documents and data relating to how a clinical trial was conducted. In recent years, driven by the digital transformation of clinical trials, we have seen the rise of the ‘eTMF’, the electronic (or digital) version of these documents.
In turn, this has caused an increased adoption of eTMF systems or solutions, used to collate and manage these large datasets throughout the trial.
They allow for the easy viewing and tracking of the documentation and reporting on key quality metrics such as completeness and timeliness. It also takes away the need for manual sharing processes such as emailing, to allow for better collaboration between the teams and organisations. In short, I’d go as far to say that they are an essential tool to manage a clinical trial.
But once the trial is over, and it is time to archive, why is the eTMF solution not suitable?
No digital preservation to ensure long-term readability
Data that is stored in its eTMF solution remains in its original format and does not benefit from any active techniques to ensure its readable in the long-term. The activities in question comprise of digital preservation techniques such as automated file format conversion. This ensures that copies of files are maintained in formats that are always readable to guarantee future use.
Without this, records could be at risk of being unable to be opened or read by future devices or software.
No automated data integrity checks
Where documents are required to remain complete and original for many years, there is the inevitable risk of data becoming corrupted, lost or damaged. Despite our best efforts, the bits and the bytes for any record can simply become corrupted.
Unlike eTMF solutions, a dedicated archive will automatically conduct checks on the integrity of the data to check for any corruption or damage.
These checks mean that any issues can be identified and resolved long before access may be required. For example, a dedicated archive should store data in at least two different geographic locations, so when an issue is identified, the ‘good’ version of the data can be copied to replace anything that has become corrupted.
Risk of vendor lock in
Keeping your data in its eTMF solution after the clinical trial has ended, puts its portability at risk in the long-term. Storing multiple eTMFs within the solution over many years can make future data migration an extremely difficult and complex task, thereby locking you in with the current vendor.
Selecting a vendor neutral archive allows for complete control of your data. You’ll have the flexibility to switch eTMF providers with less hassle despite how much data is stored there.
Potential for unmanaged and spiralling costs
eTMF solutions can quickly become costly, especially when managing large numbers of studies and sites. These costs often continue when after the conclusion of the trial, and once the system has been ‘locked’.
Storing these records in a dedicated archive by comparison, can be much more cost effective, with various storage options depending on your future access needs. Retaining your long-term records in a single repository also ensures that these costs are much more easily managed over the long-term.
Using an eTMF solution as an archive could risk future access and use of valuable records, and become costly to maintain. These are elements specifically referenced within regulations such as EU 536, where it states:
“The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.”
Retaining your eTMF data within a dedicated digital archive (such as Arkivum’s solution) archives records in line with best practice approaches and GCP retention regulations, enabling data to be easily accessed, if required for future use.
Worried about migrating your data?
We often find customers are concerned about the level of effort required and the imagined integrity risks to data during the process. However, by working with data migration experts, you can limit the risks involved in the migration process while also identifying missing data and thereby improve the quality and completeness of the eTMF.
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