Attribution, and the cohort waiting on it

A Principal Investigator scenario. Setting: Phase 1 first-in-human — dose level 3 DLT review, cohort 4 scheduled. About 10 minutes.

You are working with Sponsor Medical Monitor, Safety Review Committee chair. 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, D1.

Anchored to ICH E6(R3) §2.8 — the investigator assesses causality. At a threshold of 'at least possibly related', an alternative explanation does not by itself exclude the drug.; ICH E6(R3) §2.6 — the investigator conducts the trial in compliance with the protocol. Cohort expansion rules are protocol terms, not preferences to be traded against timelines..

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.