The Regulatory Binder Sweep

A Clinical Research Coordinator scenario. Setting: Oncology Phase II — Pre-Monitoring Prep. About 12 minutes.

You are working with Site CRA, IMV arrives in 48 hours. 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, D6.

Anchored to ICH E6(R3) Appendix C — essential records must be organized, retrievable, and current. Superseded ICFs are filed as historical, not co-active.; ICH E6(R3) Appendix C — CV, financial disclosure (21 CFR §54), and medical license are required for every listed sub-investigator before they can perform delegated tasks.; ICH E6(R3) §2.3 — PI is responsible for the delegation of trial-related duties; the DOA log must be signed by the PI before delegated tasks are performed and re-signed at each delegation change..

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.