The regulation requires a responsible party (who is also the manufacturer of the drug, biological, or device product studied in the voluntary submission) to submit clinical trial information for triggered trials no later than the later of the following two dates: (1) the date that the relevant application or premarket notification was submitted to FDA or (2) the date that clinical trial information was submitted to ClinicalTrials.gov for a trial subject to the voluntary submission requirements (42 CFR 11.60(a)(2)(iv)(B), 42 CFR 11.60(b)(2)(iv)(B), or 42 CFR 11.60(c)(2)(iv)(B)). The following scenarios relate to the timing of the submission of information for triggered trials:
- Scenario 1: The responsible party voluntarily submits clinical trial information under 42 CFR 11.60 after the application or premarket notification is submitted to FDA. In this situation, if the application or premarket notification was submitted to FDA on or after September 27, 2007, the responsible party is required to submit the triggered trial information at the time the clinical trial information is voluntarily submitted under 42 CFR 11.60, regardless of how much time has passed between the application or premarket notification submission and the voluntary submission (42 CFR 11.60(a)(2)(iv)(B), 42 CFR 11.60(b)(2)(iv)(B), or 42 CFR 11.60(c)(2)(iv)(B)). For example, if the manufacturer submitted a new drug application (NDA) to FDA on January 1, 2008, and the responsible party voluntarily submitted registration and results information to ClinicalTrials.gov for one of the clinical trials required to be submitted to FDA for that NDA on January 1, 2018, the responsible party would also be required to submit the registration and results information for any other triggered clinical trials on the same date, that is, January 1, 2018 (42 CFR 11.60(a)(2)(iv)(B)).
- Scenario 2: The responsible party voluntarily submits registration information under 42 CFR 11.60 before the application or premarket notification is submitted to FDA. In this situation, if the information was voluntarily submitted on or after September 27, 2007, the responsible party is required to submit registration information for the triggered trial by the time the application or premarket notification is submitted to FDA, regardless of how much time has passed since the voluntary submission (42 CFR 11.60(a)(2)(iv)(B), 42 CFR 11.60(b)(2)(iv)(B), or 42 CFR 11.60(c)(2)(iv)(B)). For example, if the responsible party voluntarily submitted registration information on January 18, 2018, for a clinical trial initiated on January 18, 2018, and the manufacturer is required by FDA to submit this clinical trial for an NDA that is submitted on January 1, 2020, the responsible party would also be required to submit the registration information for any other triggered clinical trials by the NDA submission date, that is, January 1, 2020 (42 CFR 11.60(c)(2)(iv)(B)).
