Thirty minutes to spin, and a centrifuge that stops

A Specimen Processing Technician scenario. Setting: Phase 1 first-in-human — day 1 intensive PK, plasma processing. About 8 minutes.

You are working with Laboratory Supervisor, Phase 1 unit laboratory. 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: D2, D6.

Anchored to ICH E6(R3) §4.1 — the record must reflect what happened. A stability window is an analytical constraint, and a sample outside it is a different sample.; ICH E6(R3) §2.5 — adequate facilities for the trial's duration. A single point of failure across a whole PK day is a resourcing issue to raise, not to absorb..

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.