ICSR Reporting Timeline Calculator

Determine the expedited reporting clock for an individual case safety report from the day of awareness and its classification (SUSAR fatal/life-threatening, other serious, or non-serious) per ICH E2A and EU GVP.

WHAT THIS CALCULATES

The due date for an expedited individual case safety report, counted in calendar days from the day of awareness, and how many days remain. Day zero is the day anyone in your organisation first became aware of the minimum criteria — not the day the case reached pharmacovigilance.

THE METHOD

dayZero

the day of awareness — when anyone in the organisation first had the four minimum criteria: an identifiable patient, an identifiable reporter, a suspect product, and a suspect reaction

window

7 calendar days for fatal or life-threatening SUSARs, 15 for other serious cases, 90 for non-serious EU cases

dueDate

the date the report is due

daysRemaining

negative once the window has passed

Calendar days, not business days — weekends and holidays are inside the clock. All arithmetic here is done in UTC on whole days, so a submission window is never shifted by an hour across a daylight-saving boundary. For a fatal or life-threatening SUSAR the 7-day initial report is followed by the complete follow-up within a further 8 days, 15 in total.

THE INPUTS, AND WHAT THEY MEAN

Day of awareness (day zero)

The date the four minimum criteria were first known to ANYONE in your organisation — including a sales representative, a medical information line or a partner under a safety data exchange agreement. This is where organisations most often lose days they cannot recover.

Case classification

Determines the window. Seriousness and expectedness are regulatory determinations against the reference safety information, not clinical impressions, and reclassification restarts nothing — the clock still runs from the original day zero.

HOW TO READ THE OUTPUT

• ›The clock starts at organisational awareness, not at receipt by pharmacovigilance. Internal transfer time is inside your window, which is why intake routes and partner agreements matter more to compliance than the reporting step itself.
• ›Reclassifying a case does not reset day zero. If a case is upgraded to serious on day 10, the 15-day clock has already been running for 10 days.
• ›Late reporting is a standing inspection finding in its own right — separate from whatever the case describes, and readily visible in a database review.
• ›Regional rules differ in ways this does not model. Confirm the specific requirement against FDA 21 CFR 314.80, EU GVP Module VI, and any local variation before relying on a date.

WORKED EXAMPLE

A fatal SUSAR where a country affiliate learned of the case on 1 July but it reached global pharmacovigilance on 6 July.

Day of awareness

1 July 2026 — the affiliate’s date, not PV’s

Classification

SUSAR — fatal or life-threatening (7 days)

Today

6 July 2026

Five of the seven days were consumed before pharmacovigilance saw the case, leaving two. Had day zero been taken as the date of PV receipt, the tool would have shown seven days remaining and the report would have been five days late — the single most common way an expedited reporting timeline is missed, and one that a database review surfaces immediately.

REGULATORY BASIS

ICH E2A

Clinical safety data management: definitions and standards for expedited reporting, including the minimum criteria for a valid case and the 7- and 15-day windows.

EU GVP Module VI

Collection, management and submission of reports of suspected adverse reactions — the EU expedited reporting obligations, including the 90-day non-serious window.

21 CFR 314.80

US postmarketing reporting of adverse drug experiences, including 15-day alert reports.

ICH E2B(R3)

The electronic transmission standard the report itself is submitted in.

LIMITATIONS — READ BEFORE YOU RELY ON THIS

• ›This is an analytical aid, not a validated system. Reproduce the date under your own pharmacovigilance procedures before relying on it — the windows and the day-count convention are published above so you can.
• ›It does not determine seriousness, expectedness or causality. Those are assessments against your reference safety information, and they decide which window applies.
• ›It models the common ICH and EU windows only. Local requirements, clinical-trial-specific obligations and product-specific commitments can differ.
• ›It counts calendar days from the date you enter. If day zero is recorded wrongly — the most frequent failure — the due date is confidently wrong.

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