Nothing is expected on a first-in-human

A Pharmacovigilance scenario. Setting: Phase 1 first-in-human — case intake, fatal event in cohort 2. About 8 minutes.

You are working with Drug Safety Physician, Case reviewer. 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: D3, D4.

Anchored to Expectedness is judged against the reference safety information for the product. Preclinical findings are not reference safety information for a human event.; ICH E6(R3) §3.10 — the sponsor evaluates safety information on an ongoing basis. A cluster in one cohort is a signal question, not three separate case questions..

Trial phase: 1.

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