A responsible party must submit certain clinical trial information for trials subject to the voluntary submission requirements under 42 CFR 11.60. The information that must be submitted is determined by the initiation date (that is, the Study Start Date) and the Primary Completion Date and is described in 42 CFR 11.60(a)(1), 42 CFR 11.60(b)(1), and 42 CFR 11.60(c)(1)).
A responsible party who submits information for a trial subject to the voluntary submission requirements must also submit clinical trial information about certain other ACTs (referred to as “triggered trials”) if clinical trial information for those ACTs has not already been submitted to ClinicalTrials.gov. These requirements are described in 42 CFR 11.60(a)(2)(ii), 42 CFR 11.60(b)(2)(ii), and 42 CFR 11.60(c)(2)(ii).
