For clinical trials initiated on or after January 18, 2017, the regulations at 42 CFR 11.64(a)(1)(ii) specify update requirements. In general, clinical trial registration information submitted to ClinicalTrials.gov must be updated not less than once every 12 months. The regulations further require that some data elements be updated more rapidly, as summarized in the Table below. In addition, if a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, the regulations require that updates to any relevant clinical trial information be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board. See the Final Rule preamble (81 FR 65109-17) and the regulations at 42 CFR 11.64 for a more complete elaboration and specification of these requirements.
