Introduction
As clinical trial sponsors, CROs and sites generate more digital records, documents and data, it is becoming increasingly important to adopt the right strategy and approach for their long-term management.
These challenges need a new way of thinking. A new approach.
Regulators are beginning to make greater demands on how data is archived, in conjunction with an increase in the number of systems and eClinical solutions adopted across the data lifecycle.
This is putting pressure on stakeholders to find the right approach to data archiving. How do I ensure that digital content is retained in line with regulations and regulatory guidance, as well as ensuring the effective management of those records over extremely long periods of time. This is before even taking into account the resources and costs required to achieve this.
These challenges need a new way of thinking. A new approach.
It’s no longer possible to simply leave data where it is or treat it like a piece of paper. To guarantee data is accessible and usable for decades, it must be actively maintained and managed throughout that period.
This guide seeks to provide practical considerations and steps that any organisation responsible for managing GCP records and data can take, to ensure their valuable digital assets are future proofed.
Let’s get started!
Regulators are beginning to make greater demands on how data is archived
Maintaining data integrity and ALCOA+ for decades
The ALCOA+ (or ALCOA++) principles have now been almost universally adopted by regulators around the world, as the set of principles organisations must adhere to in order to maintain data integrity. Created by the FDA, they are referenced within regulatory publications such as the EU Guidelines on Computerised Systems and ICH E6 (R3). You can even see the language of the principles used explicitly within regulations such as EU CTR.
A common misconception we often encounter at Arkivum, is that if an organisation is applying ALCOA+ to live data (as in data recently generated or in use day to day), then ALCOA+ will be maintained throughout the entire retention period.
This could not be further from the truth.
Let’s take the principle ‘Legible’ as an example. Ensuring documents and data created this year are legible is fairly easy. Any device with the right software should be able to recognise, open and read the majority of common formats in use today.
But what about 20 years from now?
The devices, hardware and software we’ll be using in 2045 will be very different from what it is today. I would argue it’s highly unlikely, whatever the device is, that it would be hard pushed to open a word document or email thread created in 2024.
Ensuring legibility therefore becomes a lot more challenging. How do I guarantee that my digital content will be legible for decades into the future?
And this is just taking into consideration a single ALCOA+ principle.
Throughout this guide we will be highlighting various considerations and approaches you will need to overcome, in order to ensure alignment to the ALCOA+ principles. Where applicable, we’ll connect the concepts that we’re introducing to the ALCOA+ principles within the context of long-term data management.