In accordance with HHS and FDA regulations 45 CFR 46.109(e), 21.CFR 56.109(f), a continuing progress report must be submitted for review and approval at intervals appropriate to the degree of risk, but not less than once per year. Factors for making the decision about the frequency of review include the level of risk, location of the study, and any other factors that might affect the welfare of the subjects. Frequency of review is determined by the IRB upon initial review and each subsequent continuing progress report review.
Refer to New MCW/FH Standard Operating Procedures (SOPs) "Submission of Continuing Progress Reports (CPR)" for more information.