Regulations for IRB’s are covered under Predicate Rules – 21 CFR 50 (Protection of Human Subjects), 21 CFR Part 56 (Institutional Review Boards) and 21 CFR Part 312 (INDA – Drugs) or Part 812 (IDE – Devices), and possibly others. Since the IRB activities are covered under these Predicate Rules, the electronic records are required to be Part 11 compliant.
