Hyderabad Single Day Event
Insights into Data Integrity in the Age of Digitalization
Data Integrity is one of the most important areas of consideration for clinical development these days where use of technology support is being increasingly adopted. FDA investigators continue to cite a significant number of data integrity observations during inspection. There has been an increase in regulators taking action against data fraud or false information. They are keeping pressure on those with data integrity shortcomings, issuing a growing number of warning letters and FDA-483s every year for the last few years. The analysis below shows that the data integrity findings (largely cGMP) from FDA has increased from just 4 instances in 2004 to 56 in 2017 which is around 37% of the total number of data integrity findings in 10 years across the globe.
(*)Courtesy: Barbara Unger, Unger Consulting Inc (here)
Even if these findings are largely with cGMP aspects currently, the concepts of data integrity remains the same and a shift of focus to GCP in the future is imminent with the digital change and data protection policy changes across the world impacting the clinical development space. With a great change in the digital landscape globally, it would be ideal for the Clinical Data Management Community to discuss and understand more about the opportunities and challenges of fundamental Data integrity principles being implemented in the new digital world of affairs.