FDA GUIDANCE · FINALFebruary 5, 2025

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Investigation & Enforcement, Good Clinical Practice (GCP), Pediatric Product Development

Issue date

February 5, 2025

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