An Introduction to The ALCOA++ Principles [Video]

Learn how the ALCOA++ principles safeguard data integrity in clinical trials and why regulators treat them as the backbone of Good Clinical Practice and Good Manufacturing Practice.

In this explainer, we break down the original five ALCOA attributes—Attributable, Legible, Contemporaneous, Original, and Accurate—and the five additional ones: Complete, Consistent, Enduring, Available when needed, and Traceable. You’ll hear how these attributes keep records reliable and inspection-ready, why synchronising device clocks to external standards matters, and what regulators expect today from audit trails, certified copies, and risk-based review. We also outline practical steps for mapping data flows, validating systems at the source, training teams, and rehearsing inspections—plus the common pitfalls that can undermine compliance.

At Quanticate, our biometrics teams help sponsors apply ALCOA++ across the trial lifecycle: from electronic data capture and wearables to audit-trail reviews, validation, and inspection readiness. With proven expertise in data management, statistics, and governance, we support sponsors in building systems and processes that make integrity the default. Submit an RFI today.