Abstract

Data Integrity: Hype, Myth, Fallacies and Reality

Umesh Banakar, Professor and President, Banakar Consulting Services

It is all now a common occurrence that social media lights up with copy of the observations of a(ny) regulatory Agency, especially if it is the US FDA, EMA, WHO, among others, even before the ink of the signatures of auditors/inspectors have dried !! Almost concurrent to this observation is the intense urge to pinpoint the so-called ‘data integrity issues’, count them and then cross compare against their own such observations that one is grappling with and/or have received in the recent past. Additionally, consultants and consulting agencies have mushroomed and so are the number of publications attempting to address this so-called ‘data integrity issues’.

Data is the primary essential component to rationalize, justify, explain, etc. any scientific result, conclusion, proof, and the like. It has been in existence before our lifetime in the scientific as well as non-scientific community. It has been questioned and put to test to verify the reported conclusions, results, findings, and the like. However, one wonders, why is there so much hype, curiosity of the very data now with varying lenses, at times with jaundiced eyes, now than before. It is perplexing to experience that the same data inspected/reviewed/audited by two independent Regulatory Agencies reach diametrically opposite conclusions. It is time for a reality check – feather out differences between hype, fallacies, myth and reality – or is it that the ‘trust quotient’ has sunk so low within our professional community as well as our professional commitments, actions and activities !!