Something in the Pattern — Cardiology

A Pharmacovigilance scenario. Setting: Signal Detection and Risk Management. About 9 minutes.

You are working with Aggregate safety data, Under periodic review. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D6.

Anchored to ICH E2E — potential signals documented and escalated for formal evaluation.; ICH E2E — a confounded signal is documented and kept under review, not closed on a single explanation.; ICH E6(R3) Annex 1 §2.4 — prompt communication of adverse new information to the IRB/IEC and investigators..

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