Signal Detection Form
1. General Information
Drug Name:
Drug Manufacturer:
Date of Signal Detection:
2. Signal Description
Signal Type:
Please select
Safety
Efficacy
Quality
Please describe the detected signal:
3. Data Sources
Data Source Type:
Please select
Spontaneous Reports
Clinical Studies
Literature
Social Media
Other
Please list the specific data sources used for signal detection:
4. Analysis Method
Analysis Method Type:
Please select
Statistical Methods
Data Mining Techniques
Machine Learning Algorithms
Other
Please describe the specific analysis method used for signal detection:
5. Actions Taken
Type of Action Taken:
Please select
Label Change
Risk Management
Further Investigation
Other
Please describe any actions taken in response to the detected signal:
Submit Signal Detection