A transfer of ownership of trial data should be reported to which entity?

• A. Investigators
• B. Regulatory Authorities
• C. Sponsor
• D. IRB/IEC

Answer: (B)

When data ownership changes, the main idea is that regulatory oversight requires a clear, officially recorded trace of who is responsible for the trial data. Regulatory authorities must be informed so they can update the official regulatory record, ensure continuity of oversight, and maintain data integrity and archiving. Investigators oversee subject protection and study conduct, but they don’t manage the regulatory record for ownership changes. The sponsor manages data and regulatory submissions, but the notification itself goes to the regulatory authorities, not to the investigators or the sponsor as the recipient. The IRB/IEC focuses on participant protection and ethical review, not on ownership or regulatory responsibility changes.