Putting It Together — the SUSAR Decision Path

Module 1 introduced the SUSAR definition by name early in this course — Suspected, Unexpected, and Serious, all at once — as part of the core vocabulary every PV professional needs on day one. This module has spent nine lessons building up exactly what each of those three words actually requires in practice, and this lesson is where they come back together, now with the mechanics behind each visible.

"Suspected" comes from the causality assessment this module opened with: is there at least a reasonable possibility the drug caused the event, per WHO-UMC, Naranjo, or an organisation’s chosen method — and, as Lesson 6.6 covered, this uses the more cautious of the reporter’s and the company’s assessments, not just the company’s. "Serious" comes from the six ICH E2A criteria in Lessons 6.7 and 6.8 — any one criterion met, including the "other medically important condition" catch-all, is sufficient. "Unexpected" comes from Lesson 6.9’s expectedness comparison against the CCSI, matched on nature, severity, and specificity, not just organ system or general category.

All three have to be true at the same time for a case to be a SUSAR. A serious, unexpected event that the assessor genuinely believes is unrelated to the drug is not a SUSAR — it’s a serious, unrelated event, still worth tracking but not subject to the same expedited reporting clock. A serious, suspected-related event that’s already listed in the CCSI is not a SUSAR either — it’s a serious, expected, related event, reportable through routine channels rather than the accelerated ones. Only when suspected, unexpected, and serious are all simultaneously true does the case trigger the tightest reporting timelines: 7 calendar days for fatal or life-threatening SUSARs, 15 days for other serious SUSARs, as Module 1 covered.

This is exactly why an error in any one of the three underlying assessments matters so much — a causality assessment that’s too conservative can cause a genuine SUSAR to be missed and reported late; an expectedness assessment that misses a severity or specificity mismatch can do the same. The reliability of the entire expedited reporting system rests on each of these three individually disciplined judgment calls being made correctly, case after case — which is exactly the discipline this whole module has been building toward.