Which statement best describes the documentation sponsors must obtain from the IRB/IEC to demonstrate ongoing approval and status changes?

• A. Only the initial approval with no follow-up unless requested.
• B. Documented initial and subsequent IRB/IEC approval or favorable opinion, as well as any termination or suspension of approval.
• C. Periodic safety reports to the sponsor.
• D. Audit reports from regulatory authority.

Answer: (B)

The key idea is that sponsors must have a current record showing the study is under IRB/IEC oversight and any changes in that status. ICH GCP requires continuing review and a written IRB/IEC approval or favorable opinion for the study to proceed beyond initial approval, and sponsors should retain documentation of all subsequent approvals. If the IRB terminates or suspends approval, that action must be documented as well. This ensures ongoing protection of participants and accountability to oversight bodies, with clear evidence that the study is still approved and that any status changes are captured.

Other options don’t fit because periodic safety reports are about subject safety data, not IRB status; regulatory authority audits are external inspections and not the IRB’s approval documentation; and having only the initial approval without ongoing confirmation fails to demonstrate continued IRB oversight.