Fourteen Days to Inspection

A Clinical Trial Assistant scenario. Setting: Study Operations — Inspection Readiness. About 10 minutes.

You are working with Clinical Trial Manager, Announces an authority inspection. 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, D6.

Anchored to ICH E6(R3) Appendix C + DIA TMF Reference Model — the TMF must be complete and contemporaneous; genuine gaps are documented honestly, never fabricated..

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