Who has responsibility for study monitoring when the sponsor uses contract quality assurance?

• A. The sponsor's usual contract QA
• B. The facility QA at the contractor site
• C. FDA GLP compliance officer
• D. The investigator

Answer: (A)

In GLP, the sponsor is ultimately responsible for the quality and integrity of the study. If the sponsor uses contract quality assurance, that external QA function operates as the sponsor’s agent to monitor the study, perform audits, and verify compliance with GLP across sites. This arrangement keeps monitoring independent from the day-to-day site operations and helps identify issues before they impact data.

The facility QA at the contractor site handles that particular site’s internal processes, which isn’t the sponsor’s overarching monitoring role. The investigator conducts the study, but the day-to-day responsibility for ensuring GLP compliance and data integrity lies with QA. The FDA GLP compliance officer enforces regulations but does not perform routine study monitoring.