How-Tos

Include Informed Consent Document Language for Registered Clinical Trials

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.