Definition

Report of a serious unexpected ADR submitted to authorities within defined timelines (e.g., 7 or 15 days from Day 0).

Example

15-day report to EMA and FDA for serious, unexpected, confirmed case.

Regulatory source

ICH E2D, GVP Module VI, 21 CFR 314.80

Common mistakes

Missing Day 0 or using wrong timeline for region.

Inspector question

How do you determine expedited reportability and timeline per region?

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