The Change That Is Not Substantial — Rare Disease

A Regulatory Affairs scenario. Setting: Regulatory affairs. About 8 minutes.

You are working with The change log, Non-substantial by definition. 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: D2, D6.

Anchored to EU CTR 536/2014 — substantial means affecting safety, rights or scientific value. Everything else is a notification at most.; EU CTR 536/2014 — a regulator's review capacity is finite, and every unnecessary submission spends some of it..

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