Guided Notes

Capstone: Build and Manage a Mini Clinical Study

Bring it all together: from a mini protocol to DMP, CRFs, EDC build, edit checks, UAT, simulated data entry and queries, coding, reconciliation, metrics and a mock database lock.

The brief

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You're the data manager for a fictional Phase 2 trial: 'A 12-week randomized, double-blind study of Drug X vs placebo in 60 adults with mild hypertension. Primary endpoint: change in seated systolic BP at Week 12.' Visits: Screening, Day 1, Week 4, Week 8, Week 12/EOT, Follow-up. Data: demographics, medical history, vitals, central labs (chemistry), AEs, con-meds, dosing, disposition.