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
• INLINECODE1: Variables to collect
• INLINECODE2: SDTM domain

Returns

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

Example

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. 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: