What should the IRB/IEC document when reviewing a trial?

• A. The IRB/IEC should document the review by clearly identifying the trial, the documents reviewed, and the dates for approval, modifications, disapproval, or termination.
• B. The IRB/IEC should document only the final decision.
• C. The IRB/IEC should document only if the trial is terminated.
• D. The IRB/IEC should document only the names of investigators.

Answer: (A)

When the IRB/IEC reviews a trial, the records should capture a full trail of the review: clearly identify the trial, list the documents reviewed (protocol, consent forms, investigator brochure, amendments, etc.), and note the dates for approvals, modifications, disapproval, or termination. This creates a complete, auditable record of what was reviewed and the actions taken, which supports regulatory compliance and accountability. It also makes it clear when changes were approved or when a study was terminated, and ties those actions to specific documents and dates.

Partial documentation would miss important context. For example, recording only the final decision omits what was reviewed and the basis for the decision; recording only termination misses the ongoing approvals and modifications that may have occurred; recording only names of investigators neglects the formal review actions and the documents evaluated.