The Site That Is Struggling — Oncology

A Clinical Project Manager scenario. Setting: Site Management and Oversight. About 9 minutes.

You are working with An underperforming site, Under sponsor oversight. 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: D2.

Anchored to ICH E6(R3) Annex 1 §3.9 — sponsor oversight of trial conduct, proportionate to the risk identified.; ICH E6(R3) Annex 1 §2.2.2 and §3.9 — adequate site resources, and sponsor oversight of whether they remain adequate.; ICH E6(R3) Annex 1 §3.12 — persistent noncompliance is addressed, up to and including ending participation..

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