The Consent Timing Gray Zone

A Clinical Research Coordinator scenario. Setting: Screening Visit — Consent Review. About 12 minutes.

You are working with Study CRC, (you). 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: D1.

Anchored to 21 CFR §50.20 / §50.25 + ICH E6(R3) §2.8 — research procedures require prior informed consent; standard-of-care that would occur regardless may be treated differently..

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