Assertion: trial's protocol | /r/HasProperty | amended in such a manner
Facets:
Source sentences:
text: 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.
text: 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.