How should the IRB/IEC document its reviews of a proposed clinical trial?

• A. By clearly identifying the trial, the documents reviewed, and the dates for approval, modifications, disapproval, or termination.
• B. By listing only the trial name and sponsor.
• C. By recording only the dates for approval.
• D. By providing meeting minutes only.

Answer: (A)

Documenting IRB/IEC reviews requires an auditable, complete record that shows exactly what was reviewed and what happened to the study. The best approach is to clearly identify the trial and sponsor, list every document that was considered (protocol, informed consent forms, recruitment materials, investigator brochure, data safety monitoring plan, translations, and any amendments), and record the formal actions with dates: approval, required modifications, disapproval, or termination, including dates of continuing review and any amendments. This creates a traceable trail that demonstrates what was reviewed, what decisions were made, and when, which is essential for regulatory compliance and inspections and for ensuring ongoing protection of participants. Merely listing the trial name or sponsor, recording only approval dates, or providing minutes alone does not provide the full, auditable picture of the review process.