This paper describes current regulatory requirements with regards to patient safety narratives, which form an important part of clinical study reporting.
It details a proposed process for their development and review and examines ways to lessen the burden of time and cost. Areas explored in this whitepaper include:
- Format and Location
- Additional Considerations
- Information Sources
- Process
- Consistency
- Tracking
- Delivery
- Future Directions
- Individual Case Safety Reports
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