Safety Analysis (Step 6)
INFO
The current Step-by-step operating guide is maintained in Chinese. Read Step 6 after the overview. English translation will follow after that text is confirmed.
Step 6 performs in-depth narrative analysis of safety data, evaluating clinical significance of safety signals and their impact on benefit-risk assessment.
Generated Content
- Detailed narrative analysis
- Safety signal assessment
- Adverse event trend interpretation
- Preliminary benefit-risk assessment
- Comparison with state of the art
- Conclusions and recommendations
This content directly feeds into DCR narratives and CER safety sections.