The Overnight Hospitalization

A Clinical Research Coordinator scenario. Setting: Cardiology Phase III — subject phone call, Day 40. About 12 minutes.

You are working with Ms. Okafor (subject), Calls in from home after an ER 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: D5.

Anchored to ICH E2A; 21 CFR §312.32 — an event requiring inpatient hospitalization meets the seriousness criterion (SAE), independent of the investigator's causality opinion. SAEs carry expedited reporting timelines.; 21 CFR §312.32; ICH E6(R3) §2.7.2 — SAE timelines run from awareness; you report within the window with available information and follow up with the PI's causality. The clock does not pause for a signature.; ICH E6(R3) §2.7.2; Appendix C — document onset, seriousness, causality, outcome, and follow-up to resolution; ensure source, the SAE report, and the safety database reconcile..

Trial phase: 3.

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