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Golden rules for sponsor: <em>Handling of adverse events</em>
15€
Golden rules contain GCP requirements, best practice and practical examples within:
- Adverse event form design and receipt
- Data entry in safety database
- Serious adverse events
- Expectedness assessment
- Causality assessment
- MedDRA coding
- Right First Time Narrative
- Reporting
- Adverse event follow up
- Handling of pregnancies
Include examples of inspection findings when the rules were not followed.
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