Adverse Event of Special Interest (AESI) definition
Adverse Event of Special Interest (AESI) means an AE that requires reporting even if does not meet the standard criteria for seriousness, or it occurs outside the standard AE reporting timeframes for the trial;
Examples of Adverse Event of Special Interest (AESI) in a sentence
An Adverse Event of Special Interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Adverse Event of Special Interest (AESI): An adverse event of special interest is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor’s product or program, regardless of causality, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.