If a sponsor transfers trial-related duties to a CRO, who retains ultimate responsibility for the quality and integrity of the trial data?

• A. The Investigator
• B. The Sponsor
• C. The CRO
• D. The Regulatory Authority

Answer: (A)

The sponsor retains ultimate responsibility for the quality and integrity of the trial data, even when duties are delegated to a CRO. The investigator is responsible for conducting the trial at the site and for the data they generate, but the sponsor must ensure overall data integrity, proper oversight of the CRO, and compliance with GCP and regulatory requirements. The CRO performs tasks on behalf of the sponsor, under contract, but does not assume ultimate accountability for the trial’s data quality. Regulatory authorities oversee compliance, not the day-to-day responsibility for data integrity.