Who is directly responsible for data integrity and the accuracy of final reports?

• A. The study director and the quality assurance unit (QAU)
• B. The sponsor's legal team
• C. The investigators only
• D. The FDA reviewer

Answer: (A)

The key idea is that data integrity and the accuracy of final reports come from the people who oversee the trial and verify its processes. The study director is responsible for the conduct of the study, ensuring the protocol is followed, data are collected and recorded correctly, and that the final reports reflect what actually happened. The quality assurance unit provides independent oversight, auditing procedures, and validation of data handling and documentation. They check that SOPs are followed, deviations are properly documented, and actions are taken to prevent or correct errors, which helps guarantee the data's trustworthiness and the reliability of the final reports.

The sponsor’s legal team handles contracts and regulatory matters at a higher level, not the day-to-day data integrity and reporting processes. Investigators collect and generate data, but the ultimate accountability for data integrity and accurate reporting rests with the study director and QA. An FDA reviewer is an external regulator who assesses the study after the fact, not the person responsible for maintaining data integrity during the trial.