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Questionnaires are the primary data collection instruments in Carelane. They define the structure of case report forms (CRFs) used to capture participant data.

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Questionnaire Structure

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Hierarchy

Questionnaires are organized hierarchically: 
Questionnaire
├── Group (Section)
│   ├── Item (Field)
│   ├── Item (Field)
│   └── Nested Group
│       └── Item (Field)

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Components

ComponentDescription
QuestionnaireThe complete form
GroupA section containing related items
ItemAn individual field or question

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Item Types

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Text Items

TypeDescription
StringSingle-line text
TextMulti-line text area

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Numeric Items

TypeDescription
IntegerWhole numbers
DecimalNumbers with decimal places
QuantityValue with unit

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Date/Time Items

TypeDescription
DateCalendar date
TimeTime of day
DateTimeCombined date and time

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Choice Items

TypeDescription
ChoiceSingle selection from options
Open ChoiceChoice with optional free text
BooleanYes/No selection

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Special Items

TypeDescription
AttachmentFile upload
DisplayRead-only text/instructions
CalculatedAuto-computed value

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Validation Rules

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Built-in Validation

RuleDescription
RequiredField must have a value
Min/Max LengthText length constraints
Min/Max ValueNumeric range constraints
Decimal PlacesMaximum decimal digits
PatternRegex pattern matching

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Custom Validation

Questionnaires can include custom validation:
  • Cross-field validation
  • Conditional requirements
  • Business rule checks

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Conditional Logic

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Enable When

Fields can be conditionally displayed: 
If [QuestionA] = "Yes"
Then show [QuestionB]

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Enable Behavior

When multiple conditions exist:
BehaviorLogic
AllAll conditions must be true
AnyAny condition can be true
When a field has enable conditions, it’s hidden until conditions are met. Changing answers updates field visibility dynamically.

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Calculated Fields

Fields that compute values automatically:

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Types of Calculations

  • Sum of other fields
  • Averages and scores
  • Derived values (e.g., BMI)
  • Date differences

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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.

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Repeating Groups

Some sections can repeat:
  • Multiple medications
  • Multiple adverse events
  • Repeated assessments

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How Repeating Works

  1. User clicks “Add” to create a new instance
  2. All items in the group repeat
  3. Each instance has unique data
  4. Instances can be removed if allowed

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Instructions and Help

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Display Items

Read-only text providing:
  • Section instructions
  • Field-level guidance
  • Reference information

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Help Text

Individual fields can have:
  • Tooltip help
  • Extended descriptions
  • Coding guidelines

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Questionnaire Templates

Questionnaires are typically created from templates:
  1. Create template in organization library
  2. Import template into study
  3. Customize for study-specific needs
See Questionnaire Templates for creating templates.

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Version Control

Questionnaires support versioning:
  • Track changes over time
  • Multiple versions can exist
  • Active version used for data entry
Changing questionnaire structure after data collection may require migration or amendment processes.

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FHIR Foundation

Questionnaires are built on HL7 FHIR:
  • Standard Questionnaire resource
  • QuestionnaireResponse for data
  • Interoperable structure

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Best Practices

Use clear, unambiguous labels for all fields.
Group related fields together in logical sections.
Choose field types that match the expected data.
Add validation to catch errors early in the process.

Data Entry

How to enter data in questionnaires.

Questionnaire Templates

Create reusable questionnaire templates.