What You Write Afterwards — Rare Disease

A Clinical Research Associate scenario. Setting: Monitoring Visit Reporting. About 9 minutes.

You are working with Site team and sponsor, Waiting on your report. 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: D5.

Anchored to ICH E6(R3) Annex 1 §3.11.4 — monitoring findings are reported to the sponsor.; ICH E6(R3) Annex 1 §3.11.4 — monitoring reports produced in a timeframe that allows the sponsor to act.; ICH E6(R3) Annex 1 §3.11.4 and §2.5.3 — follow-up of findings, and measures 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.