Which statement best defines ALCOA?

Which statement best defines ALCOA?

• A. ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate.
• B. ALCOA is only about data integrity.
• C. ALCOA+ means data must be accessible within 24 hours.
• D. ALCOA prohibits any changes after data entry.

Answer: (A)

ALCOA is a set of data quality attributes used to ensure data in clinical trials are trustworthy. The statement that ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate is the best because it precisely defines each element: Attributable means the data can be traced to the person who recorded it; Legible means it is readable and unambiguous; Contemporaneous means it is recorded at the time of the event or as close to it as possible; Original means the data element is the original record or a verified copy; Accurate means the data correctly reflect the observation or event. ALCOA+ extends with Complete, Consistent, Enduring, Available, but the core five are captured by that definition. The other options misstate the scope or requirements: data integrity is broader than ALCOA and doesn’t specify accountability for who entered the data; ALCOA+ is not a 24-hour accessibility requirement; changes are allowed in a controlled, auditable way rather than prohibited.

ALCOA is a set of data quality attributes used to ensure data in clinical trials are trustworthy. The statement that ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate is the best because it precisely defines each element: Attributable means the data can be traced to the person who recorded it; Legible means it is readable and unambiguous; Contemporaneous means it is recorded at the time of the event or as close to it as possible; Original means the data element is the original record or a verified copy; Accurate means the data correctly reflect the observation or event. ALCOA+ extends with Complete, Consistent, Enduring, Available, but the core five are captured by that definition. The other options misstate the scope or requirements: data integrity is broader than ALCOA and doesn’t specify accountability for who entered the data; ALCOA+ is not a 24-hour accessibility requirement; changes are allowed in a controlled, auditable way rather than prohibited.