Home » Virginia IRB Gets Warning Letter for Continuing Review Failure
Virginia IRB Gets Warning Letter for Continuing Review Failure
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
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