By Jane Wood, Principal, Quality Center of Excellence
Jane Wood, Principal of YourEncore’s Quality Center of Excellence, discusses the importance of Data Integrity in any Quality system.
Let’s discuss a great topic, that of Data Integrity. Has everyone read the MHRA GXP Data Integrity Guidance and Definitions? Issued March 2018, this guideline focuses on the promotion of a risk-based approach to data management that includes data risk, criticality and lifecycle. The guideline covers all GxP’s (and in my opinion, concepts of data integrity should also be applied even before GLP, in the research arena), so this mini-article will just give a flavor of some considerations as they relate to GCP.
What is data integrity? The definition used by the FDA for internal training: is “Data are of high quality if they are fit for their intended uses in operations, decision-making and planning . . . as data volume increases, the question of internal consistency within data becomes paramount.” The ALCOA acronym used by the FDA to define expectations is: Attributable, Legible, Contemporaneous, Original, and Accurate. The MHRA additionally refers to “ALCOA+” where the “+” stands for Complete, Consistent, Enduring and Available.
Data integrity is also agnostic of the system used, be it electronic, paper, a hybrid of the two or other imaging techniques, such as photographs. Instances of data integrity failure can occur at almost any point in the creation of data for a clinical trial, so let’s talk about some multi-dimensional strategies you can consider to help prevent and mitigate data integrity issues:
As I wrote each line, I could have gotten carried away and added so much more, so I hope your data is delightful and this is enough to encourage you to learn more about this fascinating and critical topic.