adverse event of special interest
- Guideline or reference source
- ICHE2F Development safety update report
- Definition
- An adverse event of special interest (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 can be appropriate. Such an event might warrant further investigation in order to characterise and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g., regulators) might also be warranted.
- Broader Term
- adverse event
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