Prepare content for an ICH PSUR

The Periodic Safety Update Reports (PSURs) are created on a periodic basis to enable regulatory authorities to monitor the safety of a marketed product. This information is used to view new data about the product acquired from appropriate sources. It helps relate this data to the patient exposure and also indicates whether changes should be made to the product information in order to optimize the use of the product. Requirements on the due date of periodic reports may differ for different regulatory authorities.

For more information, see:

• Create Periodic Safety Update Reports (PSURs)
  
• Enter common fields information
  
• Configure subject in the report header
  
• Select products to include in ICH PSUR
  
• Select inclusion criteria
  
• Include line listing
  
• Add data elements
  
• View selected data elements
  
• Group cases
  
• Specify summary tabulations for line listing
  
• Include CIOMS reports
  
• Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials
  
• Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
  
• Add cumulative summary
  
• Add FDA PSUR support information
  
• Generate single case submission report
  
• Select summary listing
  
• Schedule the report
  
• Setup frequency of the scheduled reports
  
• Configure security level of the report
  
• Use report templates