Which GLP role is intended to provide independent oversight of study quality?

• A. Study Director
• B. Principal Investigator
• C. Intervention staff
• D. QA Unit

Answer: (D)

Independent oversight of study quality is provided by the QA Unit. In GLP, the Quality Assurance Unit operates separately from the study team and is responsible for monitoring compliance with the protocol, standard operating procedures, and GLP regulations, as well as auditing records and facilities. This independence ensures that findings are objective and that the study’s data and reports reflect true conduct and results, supporting regulatory readiness and data integrity. The Study Director handles the day-to-day management and scientific execution of the study, the Principal Investigator leads the scientific aspects in some contexts, and intervention staff carry out the procedures. None of them serve the independent quality oversight role that the QA Unit fulfills.