Which criterion should data reported to the sponsor meet in terms quality and timing?

• A. Completeness and timeliness only.
• B. Timeliness only.
• C. Privacy protection and data security only.
• D. Accuracy, completeness, legibility, and timeliness.

Answer: (D)

Data reported to the sponsor should meet multiple quality attributes: accuracy, completeness, legibility, and timeliness. Accuracy means the data reflect the true values of observations or events, preventing misinformation in analyses. Completeness ensures all required data fields are filled, so nothing essential is missing for interpretation. Legibility guarantees the data are readable and unambiguous, avoiding misinterpretation. Timeliness means the data are reported within the specified timeframes so sponsors can monitor safety, progress, and data integrity as the trial proceeds. While privacy protection and data security are crucial for protecting participants and safeguarding information, they address confidentiality and protection rather than the direct quality and timing criteria for data reporting.