The scenario
A clinical trial database supporting heart disease research tracks patient enrollment across study sites, longitudinal visits and observations, medication use, adverse events, and trial outcomes.
What is in this drawing
Read the decisions behind it.
01
Separation of enrollment from patient and trial entities to resolve many-to-many participation and track trial-specific status and treatment arm.
02
A generic observation entity under visits captures varied clinical measurements (e.g., blood pressure, biomarkers) without schema changes.
03
Adverse events and outcomes are linked to enrollment, allowing trial-level safety and efficacy analysis.
Use for research databases needing participant, protocol, site, and longitudinal data models with adverse-event tracking and outcome analysis.
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