Expedited Reporting
What does it mean in plain English?
Expedited reporting is the requirement to notify regulators about certain adverse event reports on a compressed deadline, instead of waiting for the next routine periodic report. Which deadline applies depends entirely on how the case is classified: seriousness and expectedness together decide whether it moves in days or gets folded into routine reporting.
The clock itself starts on Day 0, the date anyone at the company first became aware of the case, not the date it finished being assessed. That's why triage happens immediately: the deadline is already running before anyone has coded, causality-assessed, or fully worked the case.
How fast does the clock run?
The deadline depends on the case classification. Select one to see its clock.
Click a case type to see its clockThe fastest clock in pharmacovigilance. Starts the moment anyone at the company becomes aware, not once the case is fully assessed.
Still expedited, still urgent, just one tier down from the fastest deadline.
Already a known, listed effect. Logged for the record and rolled into routine periodic reporting instead.
Common Misconceptions
"Once the expedited report is submitted before the deadline, the case is done and closed."
That initial submission is very often the first of several. As causality gets assessed, follow-up information arrives, or the case gets medically confirmed, follow-up or amended reports are required on their own clock. Meeting the initial deadline closes the deadline, not the case.
