Summary and Key References

This module worked through three assessments that together determine some of the most consequential classifications in the entire drug safety lifecycle. Causality assessment, via WHO-UMC or Naranjo, asks whether the drug plausibly caused the event. Seriousness, via the six ICH E2A criteria, asks whether the outcome was severe enough to matter for expedited reporting. Expectedness asks whether the event is already known, matched carefully on nature, severity, and specificity against the CCSI, not just general similarity.

None of these three assessments is a checklist exercise, even though each is built around structured criteria — the whole point of the structure is to make a genuinely difficult clinical judgment as consistent as possible across assessors, not to remove the judgment entirely. Getting comfortable applying WHO-UMC’s four key criteria, Naranjo’s ten weighted questions, and ICH E2A’s six seriousness criteria — including the "other medically important condition" catch-all this module gave its own lesson to — is exactly the fluency that separates someone who can define a SUSAR from someone who can correctly determine whether a real case is one.

Key references: WHO-UMC Causality Assessment Scale documentation (Uppsala Monitoring Centre), Naranjo, C.A., et al. (1981), "A method for estimating the probability of adverse drug reactions," Clinical Pharmacology & Therapeutics, ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), CIOMS Working Group XIV Final Report (AI human-in-the-loop principles).