FDA and MHRA use the ALCOA+ framework: data should be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. Failures in integrity are among the most common Form 483 observations.
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Glossary Term
Data Integrity (ALCOA+)
Data & Safety
Also known as: ALCOA, ALCOA+, data integrity principles
The degree to which trial data are complete, consistent, accurate, and trustworthy throughout their lifecycle.
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