Consent You Did Not Take — Infectious Disease / Vaccines

A Principal Investigator scenario. Setting: Investigator Consent Oversight. About 9 minutes.

You are working with Participant and coordinator, A consent under 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: D2.

Anchored to ICH E6(R3) Annex 1 §2.8.7 and §2.8.8 — the signature confirms the information was accurately explained and consent freely given; §2.3.2 supervision is proportionate to risk.; ICH E6(R3) Annex 1 §2.8.11 and §2.8.12 — participants are informed in a timely way of information relevant to their willingness to continue; revised materials need IRB/IEC approval.; ICH E6(R3) Annex 1 §2.8.3 and §2.8.9 — comprehension and voluntariness are required throughout; a legally acceptable representative may be needed where capacity is affected..

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