The Query That Answers Itself — Cardiology

A Clinical Data Manager scenario. Setting: Data Management — Query Review. About 9 minutes.

You are working with EDC query queue, Open queries awaiting review. The situation unfolds as you decide, and each choice changes what happens next.

3 scored decisions, each graded against a published rubric rather than marked right or wrong.

Competency areas assessed: D3, D6, D5.

Anchored to ICH E6(R3) §3.16 — queries must be specific enough for the site to answer from source, and must not lead the answer.; ICH E6(R3) §3.11.4 — an unresolved discrepancy is escalated, not closed on assertion.; ICH E6(R3) §3.11.4 — lock readiness is judged on documented open items, not on the calendar..

You make the decisions and are scored on them against the global GCP standard (ICH E6(R3)). Free, no account needed to try.