Your First Monitoring Visit

A Clinical Research Associate scenario. Setting: One site visit, arrival to close-out. About 18 minutes.

You are working with Site team, Your first visit alone. The situation unfolds as you decide, and each choice changes what happens next.

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

Competency areas assessed: D1, D2, D3, D4, D5, D6.

Anchored to ICH E6(R3) §3.11 — a monitoring visit that does not close the last one's findings is a visit that taught the site nothing.; ICH E6(R3) §3.11.4 — the monitor raises queries. A monitor never edits site-owned data, however obvious the fix looks.; ICH E6(R3) §3.10 — a deviation exists whether or not anyone recorded it. An unrecorded one is two findings, not one.; ICH E6(R3) §2.10 — three unaccounted-for units of investigational product is an accountability event, not an arithmetic disagreement.; 21 CFR Part 50; ICH E6(R3) §2.8 — a study procedure performed before consent is a serious finding regardless of outcome.; ICH E6(R3) §3.11 — a finding is a fact about the data, and it does not become less true because a previous monitor missed it..

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