A Possible Signal

A Pharmacovigilance scenario. Setting: Signal management. About 11 minutes.

You are working with Aggregate data, Signal review. 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: D6, D3.

Anchored to ICH E2E — a plausible alternative explanation is weighed in the evaluation; it does not by itself dismiss a signal.; ICH E6(R3) §3.15.3; ICH E2E — information affecting participant safety reaches investigators and ethics committees without waiting for certainty..

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