Which statement best describes the timing and currency of IRB/IEC approvals that the sponsor must document?

• A. IRB documentation is not required for sponsor records.
• B. Only the initial approval is required with no follow-up.
• C. Documented initial approval and any favorable opinions, as well as any terminations or suspensions, must be obtained and kept current.
• D. Only adverse event reports are required.

Answer: (C)

Ongoing ethics oversight must be documented and kept current. The sponsor is responsible for having initial IRB/IEC approval in place and for tracking any favorable opinions, as well as any terminations or suspensions, throughout the study. Approvals can expire or be affected by protocol or consent form changes, amendments, or other IRB actions, so the record must show that ethics clearance remained valid at all times the trial was conducted. This ensures that the study continues to meet ethical standards and regulatory requirements. Adverse event reporting is important for safety, but it does not substitute for maintaining current IRB/IEC approvals.