The Record Behind the Record — Oncology

A Clinical Trial Assistant scenario. Setting: Trial Administration — Electronic Records. About 9 minutes.

You are working with Study systems and documents, Under administrative control. 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: D4.

Anchored to ICH E6(R3) Annex 1 §2.12.2 and Appendix C — records attributable, legible, contemporaneous, original, accurate and complete.; ICH E6(R3) Annex 1 §2.12.10(a) and (b) — secure individual access, and the sponsor notified when permissions change.; ICH E6(R3) Annex 1 §2.12.10(e) — significant computerised-system incidents reported to the sponsor and the IRB/IEC..

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