Which statement about the Independent Data Monitoring Committee (IDMC) is true?

• A. It may be established by the sponsor to assess progress, safety data, and critical efficacy variables and advise continuation, modification, or termination.
• B. It is the responsibility of the site’s principal investigator to decide on trial termination.
• C. It is only concerned with data entry quality, not safety.
• D. It replaces the sponsor's responsibility for trial oversight.

Answer: (A)

An Independent Data Monitoring Committee is an independent panel established to monitor a trial’s safety and interim data and to advise on whether the study should continue as planned, be modified, or be stopped early. The sponsor can set up this committee specifically to review progress, safety signals, and critical efficacy endpoints, using pre-specified stopping rules and a charter to guide decisions. The goal is to protect participants and maintain trial integrity, without bias from investigators or sponsor influence.

This aligns with the statement that it may be established by the sponsor to assess progress, safety data, and key efficacy variables and to advise continuation, modification, or termination. The other options don’t fit: the principal investigator does not determine trial termination—that decision authority lies with the IDMC (often in consultation with the sponsor) based on the committee’s recommendations; the IDMC is concerned with safety and overall data integrity rather than just data entry quality; and the IDMC does not replace the sponsor’s responsibility for trial oversight, it supports and informs that oversight.