Who has ultimate responsibility for study conduct and data interpretation in GLP?

• A. The Study Director.
• B. Quality Assurance Unit.
• C. The Principal Investigator.
• D. The Regulatory Affairs Officer.

Answer: (A)

In GLP, the person accountable for how the study is conducted and how the data are interpreted is the Study Director. This role carries the overarching responsibility for ensuring the study follows the approved protocol and GLP requirements, that all procedures are properly documented, and that any deviations are managed appropriately. The Study Director also oversees data interpretation, ensures analyses are scientifically sound, and signs the final study report, attesting to the accuracy and integrity of the results for the sponsor and regulatory authorities.

The Quality Assurance Unit provides independent oversight and audits to verify GLP compliance, but it does not run the study or make decisions about data interpretation. The Principal Investigator may conduct the experimental work, but under GLP the ultimate accountability rests with the Study Director. The Regulatory Affairs Officer handles regulatory aspects and submission readiness, not the day-to-day conduct or interpretation of the study data.