Getting Safety Information Out — Infectious Disease / Vaccines

A Clinical Trial Assistant scenario. Setting: Trial Administration — Safety Distribution. About 9 minutes.

You are working with Safety letters and sites, Distribution and tracking. 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 §2.4 — prompt communication to the IRB/IEC of adverse new information affecting participants.; ICH E6(R3) Annex 1 §3.9 — sponsor oversight, including that information reaches the sites it was sent to.; ICH E6(R3) Annex 1 Appendix C — essential records that permit evaluation of trial conduct..

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