Conformance and the Audit Trail — Oncology

A Clinical Data Manager scenario. Setting: Standards and Electronic Records. About 9 minutes.

You are working with Datasets and system records, Under conformance 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: D6.

Anchored to CDISC SDTM — controlled terminology, with any deviation documented in the reviewer's guide.; 21 CFR Part 11 and ICH E6(R3) Annex 1 §4.2.2 and §4.2.4 — audit trails, and traceable data corrections.; ICH E6(R3) Annex 1 §2.12.10(a) and (b) — secure individual access; notify the sponsor when permissions change..

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