Preferred Label : Data Integrity;

NCIt definition : The overall accuracy and consistency of information and processes for data control and use.;

Alternative definition : 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 ICH E6; After MHRA GXP Data Integrity Guidance and Defintions, Revision 1, March 2018; After 21 CFR Part 11] See also ALCOA, ALCOA , ALCOA , traceability (data), data quality, electronic data transfer.;

Details


Main resources

You can consult :


https://esante.gouv.fr/sites/default/files/media_entity/documents/PGSSI-S_Guide_Pratique-Integrite_des_donn%C3%A9es-V1.1.pdf
2022
France
handbooks
Data Integrity
Stock
Privacy
data protection
equipment and supplies
computer security
Mechanism
mechanics

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10/07/2025


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