We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » PART 11 ENFORCEMENT EASED IN CLINICAL TRIALS
PART 11 ENFORCEMENT EASED IN CLINICAL TRIALS
October 20, 2004
Clinical sites using computerized systems in their trials should rely on the standards outlined in the predicate rules, rather than those listed in 21 CFR Part 11, according to a new guidance issued by the FDA.