The cohort gate, and a slipping schedule

A Clinical Project Manager scenario. Setting: Phase 1 dose escalation — cohort 4 gate, safety review committee Thursday. About 8 minutes.

You are working with Program Director, Sponsor program 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: D4, D6.

Anchored to ICH E6(R3) §3.1 — the sponsor is responsible for trial quality. A cohort gate is a quality control built into the design, not a schedule milestone to be optimized.; ICH E6(R3) §3.1 — quality management depends on risks being visible where they actually arise. A miscategorised risk cannot be mitigated by the people who own it..

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.