An amendment the next cohort waits on

A Regulatory Affairs scenario. Setting: Phase 1 dose escalation — protocol amendment for an intermediate dose level. About 8 minutes.

You are working with Regulatory Manager, Sponsor regulatory lead. 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: D3, D5.

Anchored to A change to the dose levels a participant may receive affects participant safety and the conduct of the trial. Administrative changes are those that do not.; ICH E6(R3) §3.9 and §3.14 — an amendment is assessed on the safety picture at the time of submission. Expedited reporting and amendment submission are separate obligations that inform each other..

Trial phase: 1.

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