Before It Goes Live — Rare Disease

A Clinical Data Manager scenario. Setting: EDC Build and User Acceptance Testing. About 9 minutes.

You are working with Build and validation team, Pre-production release. 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: D2.

Anchored to 21 CFR Part 11 and ICH E6(R3) Annex 1 §4.3.4 — computerised systems validated for their intended use.; 21 CFR Part 11 — documented approval by defined approvers, attributable to the individual.; ICH E6(R3) Annex 1 §4.3.4 and §4.3.5 — validation and controlled release of changes to computerised systems..

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