The TMF Gap

A Clinical Trial Assistant scenario. Setting: 72 Hours Before Sponsor Audit. About 9 minutes.

You are working with Sponsor Audit Lead, Arriving in 72 hours. 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: D1, D6.

Anchored to ICH E6(R3) Appendix C — TMF must be current and demonstrate compliance.; ICH E6(R3) §3.10.1 — quality issues must be communicated transparently.; ICH E6(R3) Appendix C — essential documents required during the conduct of the trial..

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