Before the Committee — Infectious Disease / Vaccines

A Regulatory Affairs scenario. Setting: IRB / IEC Interactions. About 9 minutes.

You are working with Ethics committee, Reviewing the submission. 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 §2.4 — written, dated approval before the trial begins at that site.; ICH E6(R3) Annex 1 §2.4 and §2.8.2 — committee approval of the protocol and participant-facing material.; ICH E6(R3) Annex 1 §2.4 — prompt communication of deviations to eliminate hazard, significant changes and adverse new information..

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