The DLT window in a cohort of three

A Clinical Research Coordinator scenario. Setting: Phase 1 first-in-human oncology — dose level 3, DLT window day 19 of 21. About 9 minutes.

You are working with Dr. Aluko, Principal Investigator. 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: D1, D6.

Anchored to ICH E6(R3) §2.8 — the investigator must report per protocol. A DLT determination is a protocol-defined judgment, not a lab flag, and cohort escalation depends on it.; ICH E6(R3) §2.7.1 and §3.3 — the sponsor is entitled to trial data through the agreed route. Who communicates a clinical judgment, and through what channel, is not the coordinator's to redefine..

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.