www.fdanews.com/articles/130795-irb-is-warned-for-not-following-remedies-to-earlier-inspection
IRB Is Warned for Not Following Remedies to Earlier Inspection
October 5, 2010
If an institution implements a policy to remedy a violation found during an FDA inspection, the agency will follow up to ensure the new policy is being followed. Bay Regional Medical Center’s IRB learned that lesson recently when it received a warning letter for failing to follow procedures and failing to conduct continuing review of research.
Clinical Trials Advisor
Clinical Trials Advisor