Documenting the Cycle 2 Day 1 Visit

A Clinical Research Coordinator scenario. Setting: Oncology Phase II — Subject 042, Cycle 2 Day 1. About 14 minutes.

You are working with Dr. Okafor (PI), Available for co-signature and clinical grading. The situation unfolds as you decide, and each choice changes what happens next.

6 scored decisions, each graded against a published rubric rather than marked right or wrong.

Competency areas assessed: D3, D5, D4, D1.

Anchored to ALCOA-C — data must be Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. ICH E6(R3) §2.12 requires source data recorded at the time of observation.; ICH E6(R3) §2.12.2 — any change to source must not obscure the original, must be dated with a reason for change, and initialed. 21 CFR Part 11 — audit trail must be secure and computer-generated.; CTCAE v5.0 — Grade 1: asymptomatic/mild; Grade 2: moderate pain, altered oral intake but able to eat modified diet; Grade 3: severe pain, unable to adequately aliment; Grade 4: life-threatening; Grade 5: death.; ICH E2A / 21 CFR §312.32 — hospitalization is an ICH seriousness criterion. Unexpected + related + serious = IND Safety Report (sponsor within 15 calendar days; life-threatening/fatal 7 days).; ICH E6(R3) §2.12 & Appendix B — concomitant medications must be captured with name, dose, route, frequency, start/stop dates, and indication linked to the reported AE/SAE.; ICH E6(R3) §3.10, §2.5.3; 21 CFR §312.66 — deviations must be documented, categorized (major/minor), reported per protocol, and CAPA-tracked. Under-window PK samples require sponsor notification..

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.