The Late SAE

A Clinical Research Associate scenario. Setting: Remote Monitoring Review. About 7 minutes.

You are working with Site CRC, Reports an SAE 5 days late. 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, D6.

Anchored to 21 CFR §312.32(c) — sponsor must report unexpected SAEs to FDA within 7 or 15 days; site→sponsor windows are typically 24h..

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