Virginia IRB Gets Warning Letter for Continuing Review Failure

December 18, 2009
Lack of continuing reviews, incorrect voting procedures, incomplete meeting minutes and inadequate written procedures are cited in a warning letter sent to Centra Health’s institutional review board (IRB). The Virginia IRB, which reviews device trials, failed to conduct continuing review at least once a year for two studies, according to the Nov. 20 letter posted recently to the FDA website. In one of the studies, the IRB did an expedited retroactive re-approval, which the agency says is improper.
Clinical Trials Advisor