Your Assessment, Not Theirs — Rare Disease

A Principal Investigator scenario. Setting: Investigator Safety Assessment. About 10 minutes.

You are working with Participant, An event under assessment. 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, D2.

Anchored to ICH E6(R3) Annex 1 §2.7.2 — the investigator's causality assessment is an independent medical judgment, recorded with its basis.; ICH E2A — divergent causality assessments are BOTH recorded; the more conservative drives expedited reporting.; ICH E6(R3) Annex 1 §2.8.11 — participants are told, in a timely way, new information that may affect their willingness to continue..

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