The Data You Sign For — Neurology / CNS

A Principal Investigator scenario. Setting: Investigator Data Review. About 9 minutes.

You are working with Site records, Reported data awaiting endorsement. 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 E6(R3) Annex 1 §2.12.5 — the investigator reviews and endorses reported data at milestones agreed with the sponsor.; ICH E6(R3) Annex 1 §2.12.2 and §2.12.6 — adequate source records; reported data consistent with source; corrections traceable and not obscuring the original.; ICH E6(R3) Annex 1 §2.12.10(a) and (b) — secure individual access to computerized systems, and notification to 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.