The Part With Your Name On It — Infectious Disease / Vaccines

A Principal Investigator scenario. Setting: Investigator Regulatory Compliance. About 9 minutes.

You are working with Site, sponsor and ethics committee, Obligations that are yours. 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.

Anchored to ICH E6(R3) Annex 1 §2.4 — written, dated IRB/IEC approval of the protocol and participant-facing material is required before the trial begins.; ICH E6(R3) Annex 1 §2.5.4 and §2.5.5 — deviation to eliminate an immediate hazard is permitted without prior approval, with prompt notification afterwards.; ICH E6(R3) Annex 1 §2.12.14 and §3.16.4 — direct access to all trial-related records for the regulatory authority; participants consented to it..

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