Why you shouldn't leave your data in a live system.

Archiving & Preservation / 05 Oct, 2022

Why you shouldn’t leave your data in a live system

Why you shouldn’t use your eTMF solution as an archive 

In recent years, there has been a shift from the traditional TMF to its electronic version, the eTMF which has subsequently led to a rapid rise in the use of eTMF systems to manage that data.   

Now, managing data in a live system is perfectly fine whilst the trial is live but once the trial finishes, keeping the data in a live system is no longer appropriate.  

And in fact, one of the top TMF archiving myths we often come across is whether clinical data can remain within the TMF after a trial has ended.  

So, I wanted to take this opportunity to break this down and reflect why retaining data in a live system (such as an eTMF solution) is not viable or compliant.   

Clinical data, documents and records 

Clinical trial data and records are collected and stored within a system that has been designed for running a live study (hence the ‘live’ aspect).  

As such, the documents within it are ‘living’ documents which could be amended and adapted as they progress throughout the trial’s duration and the use of a TMF during a trial is an essential part of GxP.  

However, many organisations believe that leaving this data in-situ is sufficient for retention regulations and purposes.  

It is not. And below is why.  

Find out more about Digital Archiving

What’s wrong with leaving data in a live system? 

Many organisations believe that their data is being retained in an appropriate manner but, it’s often just being stored as ‘read only’ access. Not only does this mean that data isn’t secure against those who shouldn’t be able to access it, but it’s not being protected by a purpose-built long-term solution.  

 Often, data held within live systems can be accessed, amended and even deleted. In regulated industries this is not acceptable. As stipulated by various rules across the life sciences, changes should be documented within audit trails and separate amended files should be uploaded alongside the original file.  

 

“Archived records may be the original record or a ‘true copy’ and should be 

protected so they cannot be altered or deleted without detection and protected against any accidental damage.” 

[MHRA GXP Data Integrity Guidance and Definitions Sec 6.17.1]. 

 

Below we’ve provided a list of some of the core capabilities a dedicated archive will provide, something not offered by most live systems: 

Data stored in multiple locations 

  • Relying on one location of retention means that if that one system goes down or becomes corrupted, you could potentially lose that data all together.  

 

Digital preservation 

  • When files remain in an eTMF system, they are simply retained in the state and format they were uploaded in and thus, do not benefit from a digital preservation solution. There is no long-term file format conversion taking place.  
  • Files are stored in their original native format they were provided so there is no long-term file format conversion. This presents the risk that the data could become corrupt or obsolete in the future.  

 

Data integrity checks 

  • No integrity checks are carried out on the data – you could therefore be retaining damaged data (either from the offset or which has become corrupted during the retention period) and there’d be no way of opening them in the future.  
  • Storage over long periods of time introduces the risk of files becoming corrupted and unusable which again, means the files are inaccessible and fail to meet a variety of guidelines and regulations. 

 

Data immutability 

  • Leaving data in situ means that it could be accessed and modified by those without permission to do so. An appropriate archival solution will ensure data immutability throughout the entire retention period.  
  • If access cannot be granted, then inspectors will likely be unable to access the contents – a critical inspection finding. 

 

‘Electronic TMFs should enable appropriate security and reliability, ensuring that no loss, alteration or corruption of data and documents occur.’ 

[EMA/INS/GCP/856758/2018 Sec 4.1.2] 

In closing 

Whilst leaving data in its current state – or existing system – may seem like the simpler option, the alternative is far better…and necessary. 

Ensuring clinical data remains accessible, readable, usable, inspection ready (and much more) requires it to be retained within a purpose-built solution for however long it is retained for. This becomes even more pertinent when you consider that differing regulatory bodies stipulate different retention times.  

For example, EU regulation 536/2014 now requires data to be kept in such a state for 25 years at the end of a trial. Whilst on the flipside, the MHRA are currently reviewing proposed updates to the upcoming publication of ICH E6 R3. 

We also find that customers often view the migration of data at the end of the trial as putting it at risk. In fact, in our experience we find the opposite occurs – by working with data migration experts you can not only limit any risk involved in the migration, it often proves a useful exercise in identifying missing data, improving the quality and completeness of the eTMF. 

Finally, it can actually be more cost-effective and sustainable to archive your data appropriately rather than leaving it in situ.  

The above is simply a brief explanation of why moving clinical data post-trial into a purpose-built solution is essential. If you’d like to speak to our team to discuss this further, please let us know.  

Why you shouldn't use your eTMF solution as an archive

Harriet Clark

Harriet is the Content Marketing Manager at Arkivum and joined the business in 2021. She is responsible for the creation of all marketing and sales content. Harriet is an Associate member of the Chartered Institute of Marketing.

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