How often should the IRB/IEC conduct continuing review of ongoing trials, considering risk level?

• A. Every six months
• B. Only at the start of the trial
• C. At least once per year
• D. Whenever the sponsor requests

Answer: (C)

Continuing review is required on a schedule that reflects the trial’s risk, but it must occur at least once every 12 months. The baseline rule is annual review, with higher-risk studies or those with new safety information potentially needing more frequent monitoring (for example, every six months). This is why the option of at least once per year is the best answer. The other options don’t fit the general requirement: reviews aren’t only at the start, aren’t dictated by sponsor requests, and aren’t universally every six months for all trials.