Your First Day On The Safety Desk

A Pharmacovigilance scenario. Setting: Pharmacovigilance — one day of cases and clocks. About 18 minutes.

You are working with The inbox, Every case has a clock on it. The situation unfolds as you decide, and each choice changes what happens next.

10 scored decisions, each graded against a published rubric rather than marked right or wrong.

Competency areas assessed: D1, D2, D3, D4, D5, D6.

Anchored to ICH E2A; 21 CFR §312.32 — the reporting clock starts when the sponsor first becomes aware, not when someone reads it.; ICH E2A — seriousness is a defined regulatory category, not a clinical opinion about how bad it felt.; ICH E2A — expectedness turns on nature AND severity. A more severe form of a listed event is unexpected.; ICH E2A — where investigator and sponsor disagree on causality, both assessments are retained and the more conservative drives reporting.; 21 CFR §312.32 — the initial expedited report is submitted within the window; follow-up information goes in a follow-up report.; ICH E2A — a narrative reports what each source said. Choosing between sources silently removes information..

You make the decisions and are scored on them against the global GCP standard (ICH E6(R3)). Free, no account needed to try.