Who defines the scope and approvals for a GLP study?

• A. The QA unit defines scope.
• B. The Sponsor defines scope and approvals.
• C. The Study Director defines scope.
• D. The Laboratory Manager defines scope.

Answer: (B)

In GLP, the sponsor holds the responsibility and authority to define what the study will address and to approve the key documents. They set the objectives, endpoints, study design, species, number of animals or samples, dosing regimens, and other essential parameters that establish the study’s scope. They also sign off on the protocol and any amendments, and must approve the final study report before it’s submitted to regulators. The Study Director handles the day-to-day conduct and ensures GLP compliance, but does not determine the overall scope. QA monitors compliance and verifies documentation, not define the scope. The Laboratory Manager provides facilities and resources, not the study’s scope. Therefore, the sponsor is the one who defines scope and approvals for a GLP study.