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“21 CFR 50.25(c): New Requirement for Consent Forms Being Enforced”

Posted by John Lehmann on Fri, Feb 17, 2012 @ 07:30 AM

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov:

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