The IND Safety Letter

A Clinical Trial Assistant scenario. Setting: Cross-Site IND Safety Distribution. About 7 minutes.

You are working with Sponsor Pharmacovigilance, Issues an IND safety letter. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D5, D1.

Anchored to 21 CFR §312.32(c) — sponsor must notify investigators of unexpected serious risks promptly..

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