The Discordant Causality Call

A Clinical Research Associate scenario. Setting: Remote Monitoring — SAE Reconciliation. About 12 minutes.

You are working with Site Investigator, Assessed the event as unrelated. 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: D4.

Anchored to ICH E6(R3) §2.5.2 (investigator judgment) + ICH E2A / 21 CFR §312.32 (sponsor's independent expedited-reporting duty on suspected relatedness)..

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