Topic | Content |
---|---|
Study drug (AL) | Indications and dosage |
 | Contraindications |
 | Drug interactions |
 | Use in pregnancy/lactation |
 | Common ADRs (frequency > 10%) |
 | Special precautions |
Study objectives | Primary and secondary objectives of the observational study (ALIVE) |
ADRs, AEs & SAEs | Minimum reporting requirements |
 | Definitions of ADRs, AEs & SAEs (including congenital abnormalities & birth defects) |
 | Detection and recognition of ADRs, AEs & SAEs |
Reporting of AEs & SAEs | Data collection requirements |
 | TFDA reporting form |
 | Novartis SAE reporting form |