Which option best reflects ALCOA as a data integrity concept?

• A. Accessible, Legible, Contemporaneous, Original, Accurate.
• B. Audit-ready, Legible, Contemporaneous, Original, Accurate.
• C. Auditable, Legible, Contemporaneous, Original, Accurate.
• D. Attributable, Legible, Contemporaneous, Original, Accurate.

Answer: (D)

ALCOA emphasizes that data in the lab must be traceable to the person who created or approved it, with a clear record of when and how it was generated. The first component, Attributable, is the key driver of accountability: it ensures there is a responsible individual for every data entry, typically shown through user IDs, signatures, or timestamps that link actions to a specific person. This linkage makes it possible to verify who did what, when, and under what circumstances, which is essential for trust, audit trails, and regulatory compliance.

Beyond attribution, the other elements—Legible, Contemporaneous, Original, and Accurate—describe how the data should look and be recorded: legible meaning readable; contemporaneous meaning recorded at or near the time of the observation; original meaning the first recorded form of the data; and accurate meaning a faithful representation of the observation. Together, these ensure data remains trustworthy and verifiable over time.

The alternatives replace the core attribution with terms like Accessible, Audit-ready, or Auditable. While accessibility or audit-readiness are important, they do not inherently guarantee who generated or approved the data. Attribution directly addresses accountability, making it the best reflection of the ALCOA concept.