Preferred Label : New Safety Information Available Amendment Reason;
NCIt related terms : New Safety Information Available;
NCIt definition : Previously unavailable safety data became available, which necessitates a change(s)
to, or formal clarification of, the protocol.;
Alternative definition : ICH: Previously unavailable safety data becomes available, which necessitates a change(s)
to, or formal clarification of, the protocol.;
Codes from synonyms : ICH M11-Reason for Amendment;
Origin ID : C218493;
concept_is_in_subset