Roche Template

When should an event be considered `related’
Guidance
FDA (2010)
• Investigators/sponsors were too cautious in their interpretation of “reasonable possibility”. They submitted reports for events that
were likely to be manifestations of disease, common, probably unrelated events, or study endpoints.
• FDA received too many SUSAR reports for which there was no evidence of `relatedness’.
• Document provides guidance and examples to illustrate “evidence to suggest a causal relationship between the drug and the event”.
EMA guideline (2012)
• For regulatory reporting purposes, all spontaneous reports are considered suspected adverse reactions unless the reporters specifically
state they believe the events to be unrelated (page 5)