The Reporting Clock

A Pharmacovigilance scenario. Setting: Expedited reporting. About 12 minutes.

You are working with Case file, Regulatory submission. 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.

Anchored to 21 CFR §312.32 / ICH E2A — significant new information starts a fresh expedited clock; a fatal outcome is the 7-day clock.; ICH E2A — expedited timelines are calendar days. Submit by the calendar deadline; do not assume an extension..

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