The impact of digital transformation on physical and digital TMF and GCP archives

Driven by COVID-19, the pharmaceutical industry has seen rapid adoption of digital technologies across the sector. This has had a significant impact on the way that clinical trials are both managed and run. Organisations accelerating their transformation efforts are looking to streamline process, improve efficiency, reduce costs and improve trial management. 

One outcome of this is that sponsors, CROs and sites are shifting managing trial documentation from physical records to digital – for most new trials run today the majority have already taken the decision to manage records digitally. For many there’s not really a choice in the matter as other changes to trial management have forced the issue, (e.g. the systems that are now being used to manage trials or the increase in decentralised trials). 

For the purpose of this blog post though, I want to focus on the impact of these changes to the archival of these records.  

Do I treat long-term digital records differently to paper ones? 

A common misconception we come across at Arkivum when considering archival, is that digital records can be treated similarly to physical ones – i.e. if they are stored somewhere safe, then they are safe and accessible for as long as they’re needed. 

We see examples of where people want to: 

• Store data on physical media such as CDs or hard drives and securely archive the hardware. 

• Maintain data within an existing live system in a locked state. 
• Store data within the cloud on a file sharing platform like Dropbox, SharePoint or OneDrive. 

The challenge here is that each of the above present unique long-term risks to the integrity of the data. We’ve talked about these in other posts and eBooks so I won’t cover this in more detail now, but I’ve placed links at the bottom of this blog post for further reading if you’re interested. 

Long-term digital records need to be properly managed and maintained for however long they need to be retained for. Technology constantly changes…and so archivists will need to adapt over to time to guarantee long term access and use. 

A couple of simple of examples every sponsor should be following includes: 

• Storing copies of multiple copies in different geographic locations. 
• Regularly checking every file for any data integrity issues. 
• Have processes in place to resolve any identified integrity issues. 
• Maintained long-term preservation copies of records to guarantee long-term use. 

The fear of data migrations 

While securely moving or shipping physical records around may not have been the easiest or cheapest process, there is a reassuring simplicity to it. It can be seen and signed for. 

At Arkivum we often find customers are nervous when it comes to data migrations. This largely comes down to two main concerns: 

• The perceived risks to data integrity throughout the process and; 
• The expectation of resource and effort required for a successful migration. 

This invariably leaves sponsors to leave digital records within existing systems in a locked state – in essence maintain the status quo. 

While this presents limited risk to the data in the short-term (say the first year or two), over the long-term, data is at serious risk of loss, corruption, inaccessibility, and obsolescence. And importantly, the longer it is left, the harder a future migration will be. 

Data migration need not be something to fear, I can only speak for Arkivum’s experience but customer data is completely safe and secure throughout the process, and we require limited input from customers during the process (typically no more than an hour a week to check work). 

Should you digitise historic TMF and GCP records for archival? 

We recently wrote a blog post on making the case for digitising historic TMF and GCP records with a view to their archival. Some of the benefits included: 

• Ease of long-term access and use – whether you are being inspected by a regulator, looking to repurpose an existing drug or researching to improve trial design a digital archive is much more accessible. Study documentation has a wealth of value that is largely inaccessible within a physical archive. A digital archive will enable access to records within minutes. 
• Cost effectiveness – although digitisation comes with a cost, once within the digital archive it is an extremely cost-effective approach to long-term record retention. This can also be adjusted to fit with current requirements, as well as scale to meet future needs. 
• Efficient management – a digital archive provides the ability to seamlessly manage the archive, providing access to those who need it and capturing appropriate audit trails of who has accessed what and when.   

If you’re interested in reading more about the topic, you can do so here. 

Summary 

I don’t believe that we’re anywhere near seeing the true impact that the shift from paper to digital record keeping will have on archiving within the pharmaceutical sector. 

Even going beyond the sector, I think there is still much to be done to effectively manage and unlock the true value of our historic data and records to inform current decision making. But for that to happen, that historic data must be accessible and usable.  

I’ll be fascinated to see what happens over the coming years as systems across the clinical space mature, and becoming better integrated. We have only just touched the surface of this digital transformation journey! 

If you’d like to discuss any of the topics I’ve covered today, do not hesitate to get in touch with me at Tom.Lynam@Arkivum.com. 

 Here’s the promised further reading:

• 4 reasons why your eTMF solution is not a viable digital archive 
• eBook: Achieving Long-Term Data Integrity Using Digital Preservation 

• eTMF retention requirements: complying with EU Regulation 536/2014