Oversight You Delegated — Rare Disease

A Principal Investigator scenario. Setting: Investigator Oversight. About 9 minutes.

You are working with Site team, Working under your delegation. 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: D1, D3.

Anchored to ICH E6(R3) Annex 1 §2.3 + §2.3.3 — the investigator is accountable for trial-related duties being performed by qualified, trained, documented delegates.; ICH E6(R3) Annex 1 §2.5.3 — deviations are documented and assessed for impact on participant safety and data reliability.; ICH E6(R3) Annex 1 §2.2.2 — the investigator must have adequate resources and qualified staff for the duration of the trial..

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