Definition

An expedited safety report submitted within 7 calendar days for fatal or life-threatening unexpected adverse reactions.

Example

A patient dies from an unexpected serious adverse reaction. Initial report with available information must be submitted within 7 days, with follow-up within an additional 8 days.

Regulatory source

ICH E2D, EU GVP Module VI

Common mistakes

Not submitting within 7 days because complete information isn't available. Initial reports should be submitted with available data.

Inspector question

How do you prioritize and expedite processing for potential 7-day cases?

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