Dose level 4, and a calculation that does not match

A Clinical Trial Pharmacist scenario. Setting: Phase 1 dose escalation — cohort 4 preparation, dose level 4 of 6. About 8 minutes.

You are working with Ade Bello, Clinical Trial Pharmacist. 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, D4.

Anchored to ICH E6(R3) §2.10.6 — investigational product must be used per protocol. Where two protocol documents disagree, the discrepancy is resolved before administration, never during.; ICH E6(R3) §2.10.4 and Appendix C — IP accountability and the resolution of a dosing discrepancy both have to be reconstructable from the record afterwards..

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.