Learn the Top 3 Areas for Improvement

Download our guide to Avoiding IRB Warning Letters

As we continue in our series of analyzing warning letter findings, we move from clinical investigators to IRBs, assessing their level of compliance with 21 CFR Part 56. A random review of warning letters issued to IRBs in recent years showed 3 key areas in need of improvement including written procedures, timeliness of continuing review, and adequate documentation.