“If a clinical trial is not subject to the rule, do investigators have to inform trial participants about the availability of clinical trial information on www.ClinicalTrials.gov? “

No, if the clinical trial is not subject to the rule (not an applicable clinical trial), then
investigators/sponsors do not need to inform participants about the availability of
information on the www.ClinicalTrials.gov website. The required statement should not
be included in informed consent documents or processes for clinical trials that are not
applicable clinical trials. However, if investigators/sponsors independently believe that
reporting data on www.ClinicalTrials.gov may influence subjects’ willingness to
participate, nothing in this regulation prevents investigators/sponsors from voluntarily
reporting trial data and informing trial participants in an appropriate manner.