Who informs the investigator when essential trial documents no longer need to be retained?

• A. The monitor.
• B. The IRB/IEC.
• C. The regulatory authority.
• D. The sponsor.

Answer: (D)

The sponsor is responsible for managing the trial’s documentation lifecycle and communicates when essential trial documents no longer need to be retained. The sponsor owns the trial records, defines the retention schedule in line with regulatory requirements, and then informs the investigator when destruction or discontinuation of retention should occur. The investigator follows those directives and ensures proper destruction with appropriate records. While the monitor verifies compliance and the IRB/IEC and regulatory authorities set and oversee retention requirements, the actual instruction to stop retaining documents comes from the sponsor.