According to GCP guidance, who should the sponsor utilize to supervise the overall conduct of the trial, handle statistics, verify data, conduct statistical analysis, and prepare trial reports?

• A. Appropriately qualified individuals.
• B. The sponsor's management team.
• C. The principal investigator.
• D. A contract research organization.

Answer: (A)

The key idea is that GCP requires the sponsor to supervise the trial through people who have the right qualifications and expertise. Tasks like overseeing the overall conduct, handling statistics, verifying data, performing statistical analyses, and preparing trial reports require specialized knowledge in statistics, data management, and regulatory requirements. Therefore, the sponsor should rely on individuals who are appropriately qualified to carry out or supervise these functions, ensuring competent oversight and data integrity. The sponsor can involve a CRO or other partners, but the people involved must be appropriately qualified for the work. The principal investigator is focused on site-level conduct, not sponsor-level statistical analyses or reporting, and a management team or a CRO alone does not guarantee the necessary individual qualifications.