The voluntary submission of information for a clinical trial under 42 CFR 11.60 can trigger the requirement that information be submitted for other clinical trials (i.e., “triggered” trials) if certain conditions in the regulation are met. The triggering requirements in 42 CFR 11.60(a)(2)(ii) or 11.60(b)(2(ii) apply if the voluntarily-submitted trial (either a “non-applicable clinical trial (non-ACT)” voluntary submission or a “pre-FDAAA applicable clinical trial (ACT)” voluntary submission) studies the use of a drug, biological, or device product for which the manufacturer (who is also the trial’s responsible party) submitted an application or premarket notification to FDA on or after September 27, 2007, for approval, licensure, or clearance for the use studied in the clinical trial. Triggered trials for which clinical trial information must be submitted are those pre-FDAAA ACTs (that is, ACTs that were initiated on or before September 27, 2007, and that reached their primary completion date before December 26, 2007) that (1) study the same use of the drug, biological, or device product in the application or premarket notification to FDA and (2) are required to be submitted to FDA in an application or premarket notification for approval, licensure, or clearance to market the drug, biologic, or device product studied in the clinical trial. A study that does not meet the definition of an ACT under 42 CFR 11.10(a) (for example, a phase 1 clinical trial of a drug or biological product, a small feasibility study of a device product, or an observational study) would not be considered a triggered trial under 42 CFR 11.60.
