The Enrollment You Have to Refuse — Rare Disease

A Principal Investigator scenario. Setting: Investigator Eligibility Decision. About 9 minutes.

You are working with Candidate and study team, An enrollment decision. 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: D3.

Anchored to ICH E6(R3) Annex 1 §2.5.2 and §2.5.4 — comply with the protocol, and deviate only where necessary to eliminate an immediate hazard; §2.5.3 — any deviation is documented and reviewed.; ICH E6(R3) Annex 1 §2.12.3 — the investigator is responsible for reviewing data relevant to the trial, including external-source data affecting eligibility.; ICH E6(R3) Annex 1 §2.5.3 — deviations are documented, reviewed, explained, and measures taken to prevent recurrence..

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