For all registered clinical trails approved on or after March 7, 2012, the following language must be included in the informed consent document per FDA regulations:
A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
It is the principal investigators responsibility to insure that this wording is included in all investigator-initiated clinical trials requiring registration at ClinicalTrails.gov. The wording is included in template language in myIRB and should be selected for inclusion.