www.fdanews.com/articles/123091-virginia-irb-gets-warning-letter-for-continuing-review-failure
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
Clinical Trials Advisor