Evidencing how your clinical trial records will be legible in 2050

When I speak with clinical, quality and regulatory teams, one question comes up again and again: why invest in a dedicated solution like Arkivum’s, rather than leaving records where they are, or storing them in a tool like SharePoint?

It’s a fair question, and one worth answering properly.

In simple terms, there are two main reasons.

1. You need the capability to maintain data integrity in line with ALCOA+ for the entire retention period, 25+ years under regulations such as EU CTR and the newer UK CTR.
2. You need to be able to evidence, particularly to regulators, how you are maintaining that integrity throughout the same period.

Taking legibility as an example

Let’s take legibility, one of the ALCOA+ principles, as an example. How do you ensure digital records stay legible for 25+ years?

Ongoing digital preservation processes, combined with the right technology, ensure records can still be recognised, opened and read by a human for as long as they need to be kept. This could include providing access to an inspector 20 years from now.

In practice this includes processes such as generating long-term preservation copies of every record, safeguarding both the original and the copy against corruption or loss, and monitoring format changes as technology evolves throughout the retention period.

Why tools like SharePoint fall short

This is where systems like SharePoint, or simply leaving records within their source system, tend to fall down. They don’t easily or natively support these processes, largely because they were never designed with long-term retention in mind.

That’s not a criticism of these systems, simply stating that they were built to solve a different problem.

For example, in the case of SharePoint it is a file sharing platform. A live eClinical systems are designed to collate and manage records throughout the trial. Neither of those have inbuilt digital preservation capability.

Evidencing your approach drives Good Clinical Practice (GCP)

This brings me to the second reason, and it’s the one I think gets overlooked most often.

The risk to a trial’s records on the day it closes is extremely low; the formats are not obsolete and the chance of a file being corrupted is small. The biggest risk at this stage is missing or incomplete documentation.

But without a data retention plan and solution mapped out, it is extremely difficult to evidence how records will remain legible throughout the entire 25-year retention period.

This includes demonstrating how you are managing the risk of data becoming corrupted, how are you managing access over the period, how are you maintaining copies of records in long-term formats and how you are monitoring changes to those formats over time.

Managing these elements will help to drive good clinical practice within your archiving setup.

In summary: No time like the present

The longer a “do nothing” approach continues, I would argue the harder it becomes to put this plan in action.

As time passes, familiarity with records for a particular study diminish, access to source systems potentially gets harder and missing records can remain undiscovered.

So to answer the initial question posed in this post, having a plan to consolidate all essential trial records at the end of the study into a single long-term and fit for purpose repository (like Arkivum) enables sponsors to not only be compliant, but to easily evidence that compliance to regulators.