Now, I’m sure you don’t need to be reminded of the volume of acronyms being thrown around the world of pharma and life sciences (we have a very handy glossary for that) but one of the most important ones you should be aware of is ALCOA (and the subsequent versions such as ALCOA+ and ALCOA+CC etc.).
In our first blog of this mini-series we defined what is meant by data integrity and why it is important within life sciences. Now, let’s move on to how data best practices can help protect and ensure data integrity remains intact throughout the lifecycle of your clinical data.
What are the key principles of ALCOA?
By and large, the ALCOA principles generally apply across the board for good data management.
It’s also worth pointing out that we see many of the ALCOA+ principles utilised in GxP guidelines and they are often referenced alongside the FDA’s 21 CFR Part 11 and the EMA’s eTMF regulations.
The core principles within ALCOA are:
Attributability: Making data attributable establishes transparency around that data. This principle requires that certain information such as who created the file (and when), and then comprehensively tracking changes, all while ensuring that original information is never lost.
Think of this as: Who acquired the data or performed an action and when?
Legibility: For recorded data to be legible it must be human readable throughout its lifecycle. This may seem easy on the surface but when you’re dealing with digital or proprietary assets, when you factor in those technological changes can make these systems illegible in the future, then you can see why this can become such a major concern for the future of your data.
Digital preservation prevents your data from becoming unreadable (which we’ll go into more detail in the follow-up to this article).
Think of this as: Can you read the data and any entries, now and in the future?
Contemporaneous: It’s essential that a record of an activity is made at the time it takes place.
Any changes or updates to the record must also be tracked via audit trails which detail when the file was created, by who and who made what changes and when.
Think of this as: Are changes to your data timestamped and recorded?
Original: Do you have both original and copies of the data? This is essential when trial data needs to be validated.
Think of this as: Are you maintaining both the original and a preserved copy of your data?
Accurate: The data must be consistent, reliable, truthful and a fair representation of the facts it’s portraying. There must be no errors or editing without documented amendments.
Think of this as: Is your data a fair representation of the facts it’s portraying?
How do these data best practice principles ensure data integrity?
Conforming to best practice principles like ALCOA supports the integrity of your data for a number of reasons.
Fundamentally, if your clinical data follows these guidelines then internal and external parties will be able to revisit your data – now and in the future – to:
- Interrogate findings and provide robust evidence behind the research findings
- Prove the science of the research you have conducted
- Enable appropriate decisions to be made. This means that if your data is untrustworthy, inaccurate, unreliable (etc.) then inspectors will be unable to verify (and possible reproduce) that data to secure marketing approval.
Whilst this may seem complex, a digital archiving and preservation solution can take away the hassle and future-proof your data.
Find out how in our final instalment of this series.
23 Mar, 2022
eBook: An eTMF Archiving and Preservation Guide – Revised for 2022
25 Nov, 2021