The Three Questions — Oncology

A Pharmacovigilance scenario. Setting: Pharmacovigilance Case Assessment. About 10 minutes.

You are working with A case awaiting assessment, Seriousness, causality, expectedness. 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: D3.

Anchored to E6(R3) Glossary — seriousness is defined by outcome, including the important medical event criterion.; E6(R3) Glossary — a reasonable possibility that cannot be ruled out is the threshold for a suspected reaction.; E6(R3) Glossary — unexpected where the nature OR severity is not consistent with the applicable product information..

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