Your First Day On The File

A Clinical Trial Assistant scenario. Setting: Study team office — one day across the trial master file. About 18 minutes.

You are working with The file, Everything the trial has to prove. The situation unfolds as you decide, and each choice changes what happens next.

10 scored decisions, each graded against a published rubric rather than marked right or wrong.

Competency areas assessed: D1, D2, D3, D4, D5, D6.

Anchored to ICH E6(R3) Appendix C — an essential document that cannot be versioned cannot be shown to be the one in force.; DIA TMF Reference Model — a document in the wrong zone is not lost, but nobody looking for it will find it.; ICH E6(R3) §2.6 — an incomplete submission is a delay. A submission known to be non-compliant is a misrepresentation.; ICH E6(R3) §2.3 — activation without a signed agreement means work is done under no contract at all.; 21 CFR Part 11; ICH E6(R3) §2.12 — a record without an attributable signature is not the record it claims to be.; ICH E2A; ICH E6(R3) §3.13.2 — the evidence that investigators were notified is as important as the report itself..

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