Intensive PK sampling, and the window you missed

A Research Nurse scenario. Setting: Phase 1 first-in-human — day 1 intensive PK, 14 timepoints over 24 hours. About 8 minutes.

You are working with Marta Reyes, Research Nurse, Phase 1 Unit. 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) §4.1 and ALCOA+ — the actual time is the datum. In PK the sampling time IS the measurement, so an approximated time is a fabricated result.; ICH E6(R3) §2.5 — the investigator must have adequate resources for the trial's duration. A foreseeable staffing gap in an intensive PK day is a resourcing issue, not a personal one..

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.