The seven-day clock on a first-in-human

A Clinical Trial Assistant scenario. Setting: Phase 1 first-in-human — suspected unexpected serious adverse reaction, day 0. About 8 minutes.

You are working with Study Manager, Sponsor study lead. 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, D6.

Anchored to A fatal or life-threatening suspected unexpected serious adverse reaction is reported to authorities within 7 calendar days of sponsor awareness, with a follow-up at 15. On a first-in-human, 'unexpected' is the default.; ICH E6(R3) §3.14 and §3.13.2 — the sponsor informs investigators and ethics committees of findings that could affect participant safety. Other sites dosing the same molecule are exactly that..

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.