During the trial, what should the investigator provide to the IRB/IEC?

• A. All documents subject to review.
• B. Only the initial protocol.
• C. Only adverse event reports.
• D. Only consent forms updated during the trial.

Answer: (A)

IRB/IEC oversight relies on the investigator keeping the board informed with every document that could affect participant protection or how the study is conducted. Throughout a trial, new information frequently emerges—protocol amendments, updated consent forms, serious adverse events, annual progress reports, and any other data that could change risk/benefit or how participants understand what they’re agreeing to. The IRB/IEC reviews these items to decide whether ongoing approval is appropriate and whether informed consent remains valid. Therefore, the investigator should provide all documents subject to review, not just a subset. Offering only the initial protocol or only one type of document would leave the board without the full context needed to protect subjects and ensure regulatory compliance.