You Noticed It First — Infectious Disease / Vaccines

A Clinical Research Coordinator scenario. Setting: Site Adverse Event Recognition. About 9 minutes.

You are working with Participant at a study visit, Something is different today. 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 E6(R3) Glossary — an adverse event is any untoward medical occurrence, whether or not related to the product.; ICH E6(R3) Annex 1 §2.7.2(b) — serious adverse events are reported immediately after the investigator becomes aware.; ICH E6(R3) Annex 1 §2.12.2 — adequate source records, attributable, contemporaneous and complete..

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