The four required sentences fulfill the need for a standardized, specific statement
concerning the availability of trial data on www.ClinicalTrials.gov for every applicable
clinical trial. After much careful thought, consideration of all comments submitted to the
proposed rule docket, and input from Institutional Review Board (IRB) members, clinical
trial directors, ethicists, and communication experts, we formulated the statement
provided in the regulation. 21 CFR § 50.25(c). Requiring word-for-word reproduction of
the statement avoids the need for individual analysis and determination of what is
appropriate to be included. The use of the statement also avoids different statements for
different trials.
