availableAutomated aCRF Annotation Tool

aCRF Annotation

Automatically generates FDA/NMPA/EMA-compliant annotated CRFs (aCRFs) from blank CRF PDFs and SDTM mapping tables. Uses fuzzy matching to locate PDF fields, intelligently places SDTM domain/variable annotation boxes, and supports multi-domain splitting, conditional annotations, overlap detection, and auto-adjustment.

What it solves

Automatically generates FDA/NMPA/EMA-compliant annotated CRFs (aCRFs) from blank CRF PDFs and SDTM mapping tables. Uses fuzzy matching to locate PDF fields, intelligently places SDTM domain/variable annotation boxes, and supports multi-domain splitting, conditional annotations, overlap detection, and auto-adjustment.

Use Cases

aCRF annotation after SDTM standardization mappingClinical trial data submission (FDA/NMPA)Automatic CRF variable to SDTM domain correspondenceAnnotation quality QC and audit logging

Key Highlights

  • Upload blank CRF PDF + SDTM mapping Excel, one-click aCRF generation
  • 4-step fuzzy matching algorithm (exact → normalized → fuzzy → form context)
  • Color-coded annotation boxes by SDTM domain, dashed borders for derived variables
  • Automatic multi-domain row splitting, conditional annotation (when/then) parsing
  • Overlap detection and smart position adjustment (up to 20 attempts)
  • Complete processing log (match status, scores, page numbers, warnings)

Entry

Next Steps

Upload a blank CRF PDF and SDTM mapping Excel to generate an annotated aCRF online.