Finding It Two Years Later — Neurology / CNS

A Regulatory Affairs scenario. Setting: Essential Documents and Filing. About 9 minutes.

You are working with The regulatory file, Under inspection readiness review. 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: D6.

Anchored to ICH E6(R3) Annex 1 Appendix C — essential records maintained so trial conduct can be evaluated.; ICH E6(R3) Annex 1 Appendix C and §2.8.2 — version control, with superseded material retained but not in use.; ICH E6(R3) Annex 1 §2.12.11 to §2.12.13 — essential records maintained, retained, with a named responsible person..

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