Suspected unexpected serious adverse reaction (SUSAR)
In Safety & pharmacovigilance
A SUSAR is a serious adverse reaction whose nature or severity is not consistent with the known safety information for the product. It must be all three things at once: serious, at least possibly related to the treatment, and unexpected. SUSARs carry the fastest reporting obligations in clinical research.
Example
Under ICH E2A and the EU Clinical Trials Regulation, fatal or life-threatening SUSARs are reported to the authority within 7 calendar days, and other SUSARs within 15 calendar days.
Related terms
Career paths that use this
Turn the vocabulary into a career
The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.
Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.