Attribution, and what you do with it

A Sub-Investigator scenario. Setting: Site — week 6 visit, new symptom reported. About 6 minutes.

You are working with Participant, Enrolled, week 6. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D4, D6.

Anchored to ICH E6(R3) §2.8 — the investigator assesses causality. A plausible alternative cause lowers likelihood; it does not by itself exclude the study drug.; ICH E6(R3) §2.8 and §3.14 — serious adverse events are reported to the sponsor immediately, and the investigator remains responsible for the medical assessment..

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