If a trial-related duty is not transferred to the CRO, who retains that duty?

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

Answer: (A)

In GCP, you can delegate many trial tasks to a CRO, but accountability stays with the sponsor. If a specific trial-related duty isn’t transferred to the CRO, the sponsor retains that duty because the sponsor is ultimately responsible for the trial’s conduct, protocol compliance, data integrity, safety reporting, and regulatory adherence. The investigator handles day-to-day site activities, but the sponsor remains answerable to regulators for duties not delegated to the CRO.