Definition

The rapid submission of serious, unexpected adverse events to regulatory authorities within specified timeframes (typically 7 or 15 calendar days).

Example

A fatal unexpected adverse reaction requires 7-day expedited reporting. A serious unexpected non-fatal reaction requires 15-day expedited reporting to most regulatory authorities.

Regulatory source

ICH E2D, 21 CFR 314.80, EU GVP Module VI

Common mistakes

Calculating business days instead of calendar days, or not accounting for different regional timeline requirements.

Inspector question

Walk me through your expedited reporting process. How do you ensure cases are identified and submitted within required timeframes?

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