PV Toolkit
The clock that runs under every serious ICSR — day zero is the date anyone in your organization first became aware of the case, not the date it landed on your desk.
Worth knowing before you rely on any calculator for this
15 calendar days for serious/unexpected is the near-universal core rule across ICH markets (FDA, EMA, and most others), and that's what this tool calculates. But exact timelines, what counts as "awareness," and follow-up-report clocks vary by jurisdiction, agreement, and case classification. This is a training and estimation tool — for a real case, follow your organization's SOP and safety database, not this page.