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[Free White Paper]

Patient Safety Narratives in Clinical Studies

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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