Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word
in informed consent documents for applicable clinical trials:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by U.S. Law. This Web site will not include information that can identify you.
At most, the Web site will include a summary of the results. You can search this Web
site at any time.”
