Prepare content for an NDA periodic report

The NDA Periodic Reports enable you to define an NDA Periodic report. You can add a new report as well as copy, modify and delete existing reports.

• You can print an Index of Cases included in the NDA report.
• If you select this option, the system lists the cases from the following sections once at the end of the configuration pages:
  • Sequential List of cases
  • Serious Listed Initial/Follow up
  • Non Serious Listed Initial/Follow up
  • Non Serious Unlisted Initial/Follow up
  • 15 Day Submission
• The page numbering for this sub-report continues from the configuration pages.
• You can separate initial case events from follow-up case events in the Summary Tabulation tab of the NDA Report.
  • If you select this option, the system counts events in the Initial section if the case is in the Serious Listed, Non-Serious Listed, or Non-Serious Listed/Unlisted sections.
  • If you select this option, the system counts events in the Follow-up section if the case is in the Serious Listed or Non-Serious Listed/Unlisted follow-up sections of the NDA report.
  • For the 15 Day events, if the case has not been previously reported in a NDA, the system counts it in the Initial section then the Follow-up section.
  • If you select List cases once under the Primary Event System Organ Class (SOC), the system displays a footnote with an asterisk ( * ) printed across all the System Organ Classes on the report and the following statement: Primary Event System Organ Class.
• If you select the Print FDA-3500A/VAERS form at the end option, the system prints the report sections in the following order:
  • Configuration (Including Case Indices (e.g. Sequential Case Listing, Listing by Seriousness/Listedness, Listing of Cases Missing Analysis)):
    • Line Listing
    • Summary Tabulations
    • MedWatch/VAERS reports at the end of the report
  • Page numbering for the MedWatch reports continue from the last page of the NDA report.
  • The configuration pages have been updated to reflect the updates made to the NDA Reports.
  • The configuration pages are printed at the beginning of the NDA report.
  • By default, these are unchecked on all the existing configured reports.

• Create NDA summary report
  
• Enter common fields information
  
• Configure subject in the report header
  
• Select products to generate the report
  
• Select inclusion criteria
  
• Include line listing
  
• Specify summary tabulations for line listing
  
• Schedule the report
  
• Configure security level of the report