The requirement for this provision was included in FDAAA Section 801. For 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 a specific statement that refers to the trial’s description on www.ClinicalTrials.gov. If, however, the informed consent is used for non-applicable clinical trials, you may be required to post information to ClinicalTrials.gov according to the new informed consent language.
