SUSAR
Medical abbreviation · Medical Research
| Stands for | Suspected unexpected serious adverse reaction |
|---|---|
| Categories | Medical |
SUSAR stands for Suspected unexpected serious adverse reaction, a medical research abbreviation.
Serious adverse event, possibly caused by the investigational product, whose nature or severity is not consistent with the reference safety information in the investigator's brochure. SUSARs must be reported rapidly to regulators and ethics committees.
Example: Fatal hepatic failure assessed as a SUSAR; regulators notified within seven days.
Usage notes
Under ICH E2A timelines, fatal or life-threatening SUSARs are reported within 7 days and others within 15 days of the sponsor learning of them. The term is mainly used in Europe and ICH contexts, while US rules speak of IND safety reports for serious and unexpected suspected adverse reactions. Pronounced "SUE-sar".
Related abbreviations
More medical research abbreviations
- 510(k) – Premarket notification (FDA section 510(k))
- AHRQ – Agency for Healthcare Research and Quality
- ARR – Absolute risk reduction
- AUC – Area under the receiver operating characteristic curve
- BTD – Breakthrough therapy designation
- CBER – Center for Biologics Evaluation and Research
- CDER – Center for Drug Evaluation and Research
- CEA – Cost-effectiveness analysis
- CI – Confidence interval
- CITI – Collaborative Institutional Training Initiative
- COI – Conflict of interest
- CONSORT – Consolidated Standards of Reporting Trials
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.