The Outdated Consent

A Clinical Research Coordinator scenario. Setting: New Subject Visit — First-In-Person. About 8 minutes.

You are working with Subject 057, Ready to consent. 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: D2.

Anchored to 21 CFR §50.27 — informed consent must use the IRB-approved current document.; 21 CFR §50.25 + IRB approval letter — when amendments affect risk, subjects must be re-consented..

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