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SAE Management and reporting
- 24/7 medical and safety coverage
- Trial-specific SAE report form including clear completion guidelines for the investigator
- Pharmacovigilance training to trial personnel
- SAE/ADR management
- Expedited Reporting
- Literature search
- AE/SAE reconciliation between the clinical database and the safety database at trial closure
Periodic Safety Reports
- Safety Risk Management Plans (RMP)
- Periodic Safety Update Reports incl. a benefit –risk section
- Annual Safety Reports and Drug Safety Update Reports (ASRs/ DSURs)
