" /> Adverse Event of Special Interest - CISMeF





Preferred Label : Adverse Event of Special Interest;

NCIt related terms : AESI; Adverse Events of Special Interest;

NCIt definition : An event (serious or non-serious) 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 can be appropriate. (ICH);

Alternative definition : ICH: A description of the processes and procedures used to define, measure, confirm, and report the occurrence of adverse events that are of special interest to the specific trial, or state not applicable.;

Codes from synonyms : ICH M11-Section 9;

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28/07/2025


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