Your First Day On The Database

A Clinical Data Manager scenario. Setting: Data management — one day between the sites and the lock. About 18 minutes.

You are working with The dataset, Everything the trial will be judged on. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D1, D2, D3, D4, D5, D6.

Anchored to ICH E6(R3) §2.13; GCDMP — an uncontrolled primary-endpoint field is a data-integrity risk, not a build preference.; 21 CFR Part 11; GCDMP — validation evidence has to be credible on its face, or it is not evidence.; ICH E6(R3) §2.13 — a query answered without examination is a query that was closed rather than resolved.; MedDRA coding conventions — the verbatim term and the clinical picture both inform the code, and the coder is accountable for it.; ICH E2A; GCDMP — a mismatch between safety and clinical databases is a reportable discrepancy, not a filing difference.; 21 CFR Part 11 — a reason for change has to explain the change, or the audit trail records nothing..

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