Which statement about IRB/IEC records is correct?

• A. The records should be discarded after a trial concludes.
• B. Only minutes of meetings need to be kept.
• C. The IRB/IEC should maintain records of its activities, minutes of its meetings, and comply with GCP and applicable regulatory requirements.
• D. Records are optional if the trial has low risk.

Answer: (C)

Maintaining documentation is essential for showing that participant protection and trial oversight are being properly managed. The IRB/IEC should keep a comprehensive set of records that document its activities, including the written minutes of meetings and the decisions taken, along with the basis for those decisions. In addition, the board must comply with GCP requirements and applicable regulatory obligations, which define what records must be kept and for how long. These records enable reconstruction of the oversight process, support audits, and ensure accountability to sponsors, investigators, and regulators. Records are not discarded after a trial ends, and they are not optional or limited to just minutes, even for low-risk studies. The retained documentation typically covers approvals, amendments, meeting records (including deliberations), ongoing determinations of risk/benefit, and communications with investigators, kept for the period specified by regulatory requirements or sponsor policy.