The regulation at 42 CFR 11.64(a)(1)(ii)(O)) specifies for applicable clinical trials initiated on or after January 18, 2017, or for which registration information was voluntarily submitted pursuant to 42 CFR 11.60(c), that "[i]f a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board." For determining the date by which the information must be updated, the preamble to 42 CFR Part 11 clarified that if there is more than one human subjects protection review board for a multi-site trial, the date of the first board approval for the amendment should be used. (81 FR 65110) This requirement applies to any human subjects protection review board and is not limited to amendments by human subjects protection review boards in the United States. Clinical trial registration information must include information for the entire study, because the entire clinical study is considered to be the applicable device or drug clinical trial. (81 FR 65013, 81 FR 65015)