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On 17 May 2018, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) released joint final guidance entitled “Institutional Review Board Written Procedures: Guidance for Institutions and IRBs.” This guidance also includes a checklist for IRBs when developing and reviewing their written procedures.
CITI Program modules are up-to-date with this guidance.
To learn more about IRB written procedures, check out our IRB Administration course that includes a specific module about HRPP/IRB policies and procedures.
