EU Regulation 536/2014 is shaking up the long-term data management requirements of clinical data. As of the 31st January 2022, a raft of new rules will come into force, but perhaps the most impactful will be that all data relating to a clinical trial must be retained and made readily available upon request for a period of 25 years from the point of trial close.
On the face of it, to some this may seem like a simple case of digital storage. But as we continue throughout this article, we will explore why this point of view will not protect your data for the long-term because as technology and data generation changes over time, relying on rudimentary storage methods will place your organisation (and TMF) at risk.
What’s the relationship between data and technology?
Advances and changes to technology, data generation and subsequent attention placed upon long-term data storage are increasing at an exponential rate. We simply cannot predict how all three of these elements will look in the next quarter of a century.
To really set the scene, let’s look back over the last 25 years.
- Facebook, Twitter, LinkedIn and Instagram hadn’t even been invented
- Streaming giants Spotify and Netflix also hadn’t been designed and become a part of our day-to-day (lockdown would have looked very different). Not only do these two examples reflect substantial technology changes, but our monumental shift in how we now consume media.
- The smartphone revolution hadn’t begun.
- Mobile payments and facial recognition were reserved for Hollywood fiction.
Moving on to a few stats…
- In 1996 it is estimated that there were 36 million global internet users. Today? 5.168 billion.
- In just 9 years, data created globally increased from ‘Just’ 2 zettabytes equates to 542 trillion copies of the War and Peace movie…
- And data storage? Offline media was the storage of choice …remember floppy disks?
Whilst the above examples likely bring a wave of nostalgia (and there are many, many more we could list), they also reflect the fact that we cannot predict how and when technological changes will occur.
But what does this have to do with your clinical data?
Digital Preservation: A very real challenge
In a previous article of ours, we discussed why offline media formats such as tape, hard drives and other such formats are at risk of degradation and obsolescence. For your clinical data, this could cause it to become lost, damaged and corrupt. Meaning? You wouldn’t be able to access and read it in the future and therefore, would not be compliant with data management regulations.
Combine these afore-mentioned technological feats and concerns with system updates, application upgrades, mass data generation, and you can see why protecting your data becomes such an important issue.
Let’s expand upon the floppy disk as our example here.
For the purpose of the story, we’ll assume that the floppy disk itself is in good condition and the data contained within it is still as it was when it was saved to it (i.e. has not become corrupted or damaged).
Firstly, you’ll need to find something which can read a floppy disk. I don’t know about you, but I certainly don’t have anything to hand either at home or in the office.
Again though, for the sake of the story, let’s say that you can access the files on the floppy disk. The next challenge arises when trying to open the file; this will very much depend on what that file is and what software you’re currently running on your machine.
Many modern software applications will struggle to open files from 25 years ago, just as in 25 years from now, most devices will struggle with files from today.
And that’s not the only problem. A good example of the type of challenge you can encounter once you’ve opened an old file is how the formatting of the text and images has been understood and presented by the new software. Common fonts used in documents over that length of time often change which can make them ineligible to humans, or pushes text around, hiding it behind other elements of the document.
This is why digital preservation must be a separate consideration (with supporting processes) to simply storing your data. If you have data which needs to be easily read for decades into the future, you need to ensure that you have digital preservation processes in place to maintain your files in line with the technology of the current day (however far into the future that may be!).
Will we even look at data we store today?
In 1997, Michael Lesk asserted that by the year 2000, “we will be able to save everything…[and] the typical piece of information will never be looked at by a human being.” Is it too presumptuous to say that perhaps this was the beginning of the need for long-term data management?
Fast forward 24 years, and we can quite confidently say that we haven’t gotten much better at only storing what we need for the long-term. After all, it’s too easy to file away all of our documents and versions of photos and assets – even if we won’t likely need them again.
Moving forward into the future, sustainability of data and its associated storage must be considered, as well as perhaps both our individual and organisational approaches to data must be appropriate/adept for the future.
We can achieve this by not only preserving them within a digital archive, but only storing what needs to be kept.
Preparing for the new tomorrow
What feels like a big shift at the time soon becomes engrained into our day-to-day and soon forget their impact …that is, until the time comes when you need to access something from a few years ago.
Whilst we can’t predict what technology will be used, or how much data there will be in the world in the year 2053, you can invest in preventative measures.
You can store your data in a solution which future-proofs them.
Digital archiving and preservation are different to traditional methods of data storage. They encompass a variety of processes upon the point of data upload and throughout the entire retention of the documents within the archive to protect their integrity and ensure the holder of their accessibility and readability.
This type of storage solution is the only assured way in which to protect your digital assets for the future. No matter the devices or applications which will be in use by individuals, organisations and inspectors up to, including, and even beyond 2053.
Responsible digital preservation is something organisations should – and must – be doing.
If you have any concerns or queries regarding your long-term data management strategy, please contact our expert team.
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