Generate Documents (CEP/CER/DCR)
Document Types
| Document | Full Name | Generation Method |
|---|---|---|
| CEP | Clinical Evaluation Plan | AI + code injection |
| CER | Clinical Evaluation Report | AI + code injection |
| DCR | Data Collection Report | Deterministic code assembly |
Document Pipeline
After all steps are approved:
- Each document shows status (Ready / Generating / Completed)
- Click "Generate" to start
- Streaming output shows progress in real-time
- Upon completion, available actions:
- Insert to Word -- insert into current document
- Download -- export as .docx file
- Preview -- view content
- Edit -- modify text
- Redo -- regenerate (confirmation required)
AI Content Labeling
All generated documents include:
- Cover page label: "AI-Assisted Document -- Generated with Reguverse Assistant"
- Word document metadata with AI generation information