What should the investigator ensure about the data reported to the sponsor?

• A. Only accuracy.
• B. Legibility only.
• C. Timeliness only.
• D. Accuracy, completeness, legibility, and timeliness.

Answer: (D)

In Good Clinical Practice, data reported to the sponsor must be accurate, complete, legible, and timely. Accuracy means the information truly reflects what was observed or measured. Completeness ensures all required data fields are filled and no relevant data are omitted. Legibility means the information can be read clearly, avoiding misinterpretation. Timeliness means data are reported within the agreed-upon timelines so the sponsor can monitor safety and progress and make timely decisions. Together, these four aspects safeguard data integrity and ensure reliable assessment of safety and efficacy. If any one area is neglected, the quality and reliability of the trial data could be compromised.