A deviation the next dose level is built on

A Clinical Research Associate scenario. Setting: Phase 1 first-in-human — interim monitoring visit, cohort 3 complete. About 9 minutes.

You are working with Site Coordinator, Phase 1 unit CRC. 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: D3, D6.

Anchored to ICH E6(R3) §3.11 — deviation significance is judged by impact on participant safety and on the reliability of the trial's results, not by count.; ICH E6(R3) §3.11.2 — significant findings are communicated promptly. Promptly is measured against the decision the finding affects, not against the reporting cycle..

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.