The Weekend SAE

A Clinical Research Coordinator scenario. Setting: Saturday Afternoon — Phone Call from Subject. About 9 minutes.

You are working with Subject 031, Calling from the ER. 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: D5, D6.

Anchored to ICH E2A — hospitalization = serious. 21 CFR §312.32 — sponsor reporting clocks start at site awareness.; 21 CFR §312.32(c) — fatal/life-threatening = 7 day, other SUSAR = 15 day.; 21 CFR §56.108(b) — unanticipated problems involving risks to subjects must be reported promptly..

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