According to the CFR and ICH GCP, an IRB/IEC must retain all relevant records for...

Record retention is critical for regulatory inspection and subject protection.

21 CFR 56.115(b):IRBs must retain records forat least 3 yearsafter completion of the research.

ICH E6(R2) 3.4.3:Similarly requires retention of records for a minimum of 3 years after completion.

This allows audits, sponsor inspections, or regulatory reviews long after the study closes. Institutions may require longer retention, but federal minimum is3 years.