Archives: Jargon
Suspected Unexpected Serious Adverse Reactions (SUSAR)
An adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction. View a flowchart (pdf, 180.98 KB) outlining the assessments required to determine whether a SUSAR has occurred.
EudraVigilance Clinical Trials Module (EVCTM)
Part of the EudraVigilance data processing network and management system to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC.
ASR
Annual Safety Report: For studies involving the use of an Investigational Medicinal Product, this is the annual report which must be submitted to the MHRA detailing all SUSARs and SARs that have occurred in subjects on that study in the past year