The Week Before Lock — Rare Disease

A Clinical Data Manager scenario. Setting: Database Lock Preparation. About 10 minutes.

You are working with Clinical and safety databases, Being reconciled. 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: D5.

Anchored to ICH E2A and ICH E6(R3) Annex 1 §3.16 — safety and clinical data reconciled before analysis.; ICH E6(R3) Annex 1 §3.10 — quality management; the lock criteria were defined in advance for a reason.; ICH E6(R3) Annex 1 §3.10 — quality issues are assessed and the root cause addressed..

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