The Reporting Clock — Oncology

A Pharmacovigilance scenario. Setting: Expedited Reporting. About 10 minutes.

You are working with Case file, Awaiting a reporting decision. 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: D4, D6.

Anchored to ICH E2A / 21 CFR §312.32 — expedited reporting requires serious AND related AND unexpected. Fatal or life-threatening is 7 days; otherwise 15.; ICH E2A — significant new information starts its own expedited clock, judged on the new facts.; ICH E2E — individual case handling does not replace aggregate signal detection..

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