The Amendment No One Re-Consented

A Clinical Research Coordinator scenario. Setting: CNS Phase II — IRB-approved amendment, Week 12 dosing visit. About 12 minutes.

You are working with Mr. Alvarez (subject) & his daughter, Returning for an active dosing visit. 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 21 CFR §50.25; ICH E6(R3) §2.8.2 — when new information may affect a subject's willingness to continue, they must be re-consented on the IRB-approved updated ICF. Continued participation on materially outdated consent is a finding.; ICH E6(R3) §2.8.9; §2.8.13 — where a subject may lack capacity, consent is obtained from a legally authorized representative per the IRB-approved process, capacity is assessed and documented, and the subject's assent is sought to the extent possible. Financial POA is not automatically an LAR for research.; 21 CFR §50.27; ICH E6(R3) §2.8.8, Appendix C — document the re-consent (date/time, version, capacity finding, LAR + assent), retain the superseded ICF as historical, and notify the PI..

Trial phase: 2.

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