Data Integrity

CDISC-Gloss – A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on “GxP data integrity”) See also ALCOA, ALCOA+, traceability (data). Compare to data quality.