Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/listings will appear along with the line listing. The system enables you to separate the cumulative summary by seriousness, relatedness, and listedness. If you choose this option, the system separates the product event detail into the following categories: Serious/Non-Serious, Related/Non-Related, and Unlisted/Listed events.

Field	Description
Include Index of Cases in PSUR	Create an index page of case numbers, for all cases included in the PSUR.
Include Summary of Cases Missing Assessments	This option creates a sub-report of cases missing one of the following items: Seriousness Case Causality Case Listedness Case Outcome Event Causality Event Listedness Click this checkbox to create one or both of the following sub reports: Cases Missing Assessments - This sub-report displays cases that have been included in the PSUR line listing, but one or more of the following have not been assessed: Case Seriousness Case Causality Case Listedness Case Outcome Event Causality Event Listedness Cases Not Included in Report - This sub-report displays cases that have not been included in the PSUR line listing as a result of missing one or more of the following items: Lock Status Safety Date Uncoded Event Causality
Include Line Listing Tabulation	Check this checkbox to view a pre-defined summary tabulation of Report type, Seriousness and Listedness of all cases in the PSUR.
Additional Expedited Report Forms (CIOMS/MedWatch/VAERS)	Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its respective regulatory agency (as selection), for all cases in the report. It also provides an option to have (or not have) a watermark in the forms.