Preferred Label : Reportable Adverse Event of Special Interest;
NCIt related terms : Reportable AESI;
NCIt definition : An adverse event of special interest that is deemed to be reportable to the appropriate
regulatory authority.;
Alternative definition : ICH: An adverse event of special interest (serious or non-serious) is one of scientific
and medical concern specific to the sponsor's product or program, for which ongoing
monitoring and rapid communication by the investigator to the sponsor could be appropriate,
and which is deemed to be reportable to the appropriate regulatory authority.;
Codes from synonyms : ICH M11-Trial-Related Safety Event Type;
Origin ID : C218512;
concept_is_in_subset
