The Missing Source Doc

A Clinical Research Coordinator scenario. Setting: Pre-Monitoring Visit Prep. About 8 minutes.

You are working with Site CRA, Arrives in 24 hours for SDV. 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) Appendix C — essential documents must be retrievable; §2.12 — source data must be original.; Industry guidance: NTFs must state what, when, who, why, and corrective action.; DIA TMF Reference Model — Zone 05 covers Site Management..

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