What it is
Rule Studio is the centralized rule management app for defining validation logic and business rules across clinical trial studies. Rules enforce data quality at the point of entry and can automate calculations, visibility, and default values on CRFs.
Rules can be scoped to an individual CRF (form-level) or to an entire study (study-level).
Who uses it
| Role | Typical use |
|---|---|
| Study Builder / Data Manager | Create and maintain edit-check and calculation rules |
| Study Administrator | Enable or disable rules before go-live |
| Site staff | Triggered by rules during data entry (failed validations become Queries) |
Key capabilities
- Auto-calculated fields (e.g., BMI from height and weight)
- Range and consistency validations across fields and forms
- Conditional field visibility based on other answers
- Default value population and cross-form logic