Questionnaire Structure
Hierarchy
Questionnaires are organized hierarchically:Components
Item Types
Text Items
Numeric Items
Date/Time Items
Choice Items
For both single-choice and multiple-choice questions, study designers can pick how options are rendered to participants and site users:
To change the display, open the question in the questionnaire editor and use the Display toggle above the option list. The setting is stored on the question and applies wherever the CRF is rendered — data entry, preview, and participant-facing forms. Selected values can be cleared by reopening the dropdown and deselecting them, and every change to a question’s display control is captured in the questionnaire audit trail.
Special Items
Validation Rules
Built-in Validation
Custom Validation
Questionnaires can include custom validation:- Cross-field validation
- Conditional requirements
- Business rule checks
Conditional Logic
Enable When
Fields can be conditionally displayed:Enable Behavior
When multiple conditions exist:How Conditions Work
How Conditions Work
When a field has enable conditions, it’s hidden until conditions are met. Changing answers updates field visibility dynamically.
Calculated Fields
Fields that compute values automatically:Types of Calculations
- Sum of other fields
- Averages and scores
- Derived values (e.g., BMI)
- Date differences
Calculation Expressions
Calculations use FHIRPath expressions to reference other fields and perform computations.Calculated fields update automatically when source values change. Users cannot manually edit calculated values.
Repeating Groups
Some sections can repeat:- Multiple medications
- Multiple adverse events
- Repeated assessments
How Repeating Works
- User clicks “Add” to create a new instance
- All items in the group repeat
- Each instance has unique data
- Instances can be removed if allowed
Instructions and Help
Display Items
Read-only text providing:- Section instructions
- Field-level guidance
- Reference information
Help Text
Individual fields can have:- Tooltip help
- Extended descriptions
- Coding guidelines
Questionnaire Templates
Questionnaires are typically created from templates:- Create template in organization library
- Import template into study
- Customize for study-specific needs
Version Control
Questionnaires support versioning:- Track changes over time
- Multiple versions can exist
- Active version used for data entry
FHIR Foundation
Questionnaires are built on HL7 FHIR:- Standard Questionnaire resource
- QuestionnaireResponse for data
- Interoperable structure
Best Practices
Clear Labels
Clear Labels
Use clear, unambiguous labels for all fields.
Logical Grouping
Logical Grouping
Group related fields together in logical sections.
Appropriate Types
Appropriate Types
Choose field types that match the expected data.
Validation
Validation
Add validation to catch errors early in the process.
Related
Data Entry
How to enter data in questionnaires.
Questionnaire Templates
Create reusable questionnaire templates.