QA officers perform audits of which items?

• A. Draft and final reports against the study raw data and the protocol
• B. Equipment logs and maintenance records
• C. Personnel training records only
• D. Environmental monitoring data only

Answer: (A)

QA audits focus on data integrity and adherence to the study plan. The key activity is verifying that the study reports—both drafts and final versions—accurately reflect the raw data and follow the protocol. This ensures that the data collection, processing, and analysis were conducted as planned, that any deviations are properly documented, and that the drawn conclusions are supported by the actual data.

While QA may also review other quality-system areas such as equipment logs, maintenance records, personnel training, and environmental monitoring data, the most essential audit in this context is checking that the reports align with the raw data and the protocol.