Which two roles share responsibility for data integrity and final report accuracy?

• A. The study director and the quality assurance unit
• B. The sponsor and the FDA
• C. The laboratory technician and pathologist
• D. The project manager and QA director

Answer: (A)

In GLP, data integrity and final report accuracy are safeguarded by the study director and the quality assurance (QA) unit. The study director is responsible for the overall conduct of the study, ensuring that data are generated, recorded, and reported truthfully. The QA unit provides independent oversight, auditing records and procedures to verify that data handling and reporting meet GLP standards and that the final report accurately reflects the study findings. Together, they share accountability for both how the data were produced and how the results are communicated.