Aggregate Reports track errors across multiple applications at the highest level, showing a summation of errors and trends amongst applications. These reports are generally used by the Agency, however, they can have specific uses for a pharmaceutical sponsor as well.
To run an Aggregate Report:
Ensure applications have been loaded and processed.
Select the Application Format. This will be based on Regional specifications.
• US eCTD
• EU eCTD
• EU NeeS, etc.
Select Start/End dates for the report.
Select Application Type.
To select several Application Types in a row (e.g., New Drug Application and Abbreviated New Drug Application), press the Shift key and click the selections. To select Application Types out of sequence (e.g., New Drug Application and Investigational New Drug Application), press the Ctrl key and click the selections.
Select Option (see Options Page).
Enter Application Number and/or Company Name to limit the applications returned.
Click Aggregate.
Choose the appropriate option from the pop up window, per Figure 6.
The following information and errors are reported in the Aggregate Report.
• Application Format
• Application Type
• Option Name
• Date Range
• Error Number and Description
• Error Group and Count
• Error Severity Level