The Date Will Not Move — Neurology / CNS

A Clinical Project Manager scenario. Setting: Study Management — Milestone Pressure. About 9 minutes.

You are working with Sponsor program lead, Holding a committed date. 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: D5, D3, D6.

Anchored to ICH E6(R3) §3.10 — quality management is risk-based; a timeline is a plan, not a quality standard.; ICH E6(R3) §2.3 + §3.10 — participant rights, safety and wellbeing prevail over the interests of science and society.; ICH E6(R3) §3.10 — quality issues are identified, assessed and acted on, with root cause addressed..

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