The Enrollment Dilemma

A Clinical Research Coordinator scenario. Setting: Oncology Phase II — Screening Visit. About 8 minutes.

You are working with Dr. Patel, Principal Investigator (off-site today). 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, D6.

Anchored to ICH E6(R3) Annex 1 §2.5.2 — the investigator is responsible for protocol compliance. Eligibility criteria are protocol requirements, so a participant who does not meet them is not enrolled; a departure is a deviation, not a judgment call for site staff.; ICH E6(R3) §2.12 + ALCOA+ — contemporaneous, attributable, original.; ICH E6(R3) §2.8.3 — communication must be honest, respectful, and protocol-aligned..

Trial phase: 2.

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