Adverse event reporting.pdf
Adverse event reporting.pdf
Adverse event reporting.pdf
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7. What is the data infrastructure?<br />
• Human receiver recognizing hazard reports<br />
• Simple spreadsheet<br />
• Relational database<br />
8. What is the approach to classification?<br />
• By <strong>event</strong> type<br />
• By risk<br />
• By causation<br />
9. What is the approach to analysis?<br />
• Hazard identification<br />
• Summaries and descriptions<br />
• Trend and cluster analysis<br />
• Correlations<br />
• Risk analysis<br />
• Causal analysis<br />
• Systems analysis<br />
10. How will responses be generated and disseminated?<br />
• Acknowledgement to reporter<br />
• Alerts generated to organizations<br />
• Trends, themes, or best practices in periodic newsletters<br />
11. Are there sufficient resources?<br />
• Mechanism for collecting reports<br />
• Database management<br />
• Capacity to investigate<br />
• Technical infrastructure<br />
• Method for classifying <strong>event</strong>s<br />
• Expert analysis<br />
• Capacity to disseminate findings and recommendations
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