Approved Before Approval — Cardiology

A Regulatory Affairs scenario. Setting: Regulatory Affairs — Amendment Handling. About 9 minutes.

You are working with Study team, Already operating the change. 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, D2, D5.

Anchored to ICH E6(R3) §2.5 + §3.8.1 — a protocol change may not be implemented before approval, except to eliminate an immediate hazard to participants.; ICH E6(R3) §2.8 — participants must be informed in a timely manner of new information that may affect their willingness to continue.; ICH E6(R3) §3.10 — quality issues are reported transparently, with root cause and corrective action..

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