| name | ecrf-designer |
| description | Design clinical trial CRFs with proper validation rules |
| version | 1.0.0 |
| category | Pharma |
| tags | [] |
| author | AIPOCH |
| license | MIT |
| status | Draft |
| risk_level | Medium |
| skill_type | Tool/Script |
| owner | AIPOCH |
| reviewer | |
| last_updated | 2026-02-06 |
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
| Risk Indicator | Assessment | Level |
|---|
| Code Execution | Python/R scripts executed locally | Medium |
| Network Access | No external API calls | Low |
| File System Access | Read input files, write output files | Medium |
| Instruction Tampering | Standard prompt guidelines | Low |
| Data Exposure | Output files saved to workspace | Low |
Security Checklist
Prerequisites
No additional Python packages required.
Evaluation Criteria
Success Metrics