In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials.
Suspected Unexpected Serious Adverse Reaction
Suspected Unexpected Serious Adverse Reaction is the term used to refer to an adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. Reports of these reactions are subject to expedited submission to health authorities.
SUSARs in the European Union
- A SUSAR is defined as an untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: results in death, is life-threatening, requires hospitalisation or prolongation of an existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect
- The responsibilities and requirements concerning SUSAR reporting are determined by Directive 2001/20/EC and a detailed guidance document (‘CT-3’)
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