The Evolution of Clinical Data Management
Table 1
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Table 1
Table
Table 1
| Area | Traditional paper-based approach | Modern electronic and reproducible approach |
|---|---|---|
| Data collection | Paper CRFs, registers, handwritten notes | eCRFs, REDCap instruments, surveys, mobile capture |
| Validation | Manual review after collection | Real-time validation rules, required fields, range checks |
| Traceability | Manual signatures and paper correction logs | Audit trails, timestamps, user-level activity records |
| Access control | Physical file control, locked cabinets | Role-based permissions, Data Access Groups, authentication |
| Monitoring | Periodic manual review | Dashboards, central monitoring, automated reports |
| Analysis preparation | Manual spreadsheet cleaning | Scripted cleaning in R, documented transformations |
| Reporting | Static tables prepared manually | R Markdown or Quarto reports, reproducible outputs |
| Archival | Physical storage and file boxes | Documented electronic archives, metadata, controlled sharing |