The Whiteout Temptation

A Clinical Research Coordinator scenario. Setting: Visit 4 Source Documentation. About 7 minutes.

You are working with Subject 042, Just left the visit room. 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: D3.

Anchored to ICH E6(R3) §2.12 + ALCOA+ (Original) — original entry must remain visible.; 21 CFR Part 11 — audit trail must capture every change with reason.; ICH E6(R3) §3.10 — quality issues should be visible to the QMS even if minor..

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