eCRF Designer

Clinical data collection form design.

Use Cases

• Case report form creation
• CDISC SDTM compliance
• EDC system setup
• Data validation rules

Parameters

• visit_schedule: Time points
• data_elements: Variables to collect
• cdisc_domain: SDTM domain

Returns

• CRF specifications
• Field validation rules
• Logic skip patterns
• Data dictionary

Example

Demographics form with edit checks for age range

Risk Assessment

Security Checklist

• No hardcoded credentials or API keys
• No unauthorized file system access (../)
• Output does not expose sensitive information
• Prompt injection protections in place
• Input file paths validated (no ../ traversal)
• Output directory restricted to workspace
• Script execution in sandboxed environment
• Error messages sanitized (no stack traces exposed)
• Dependencies audited

Prerequisites

No additional Python packages required.

Evaluation Criteria

Success Metrics

• Successfully executes main functionality
• Output meets quality standards
• Handles edge cases gracefully
• Performance is acceptable

Test Cases

1. Basic Functionality: Standard input → Expected output
2. Edge Case: Invalid input → Graceful error handling
3. Performance: Large dataset → Acceptable processing time

Lifecycle Status

• Current Stage: Draft
• Next Review Date: 2026-03-06
• Known Issues: None
• Planned Improvements:
  • Performance optimization
  • Additional feature support