Submitted by kkg4003 on August 15, 2023 - 4:05pm
Definition:
Periodic review of a research study by an IRB to evaluate whether risks to participants remain reasonable in relation to potential benefits and to verify the study continues to meet regulatory and institutional requirements. Continuing review shall be conducted at intervals appropriate to the degree of risk but not less than once per year. (45 CFR 46.109(e); 21 CFR 56.109(f))