Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency, products, etc. for which the PSUR will be applicable.

Field	Description
Primary Agency	Select the Primary Agency.
Reporting Destination	Displays the list of agencies from where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. You can select multiple agencies from the list of agencies such that the report can be submitted to multiple agencies at the same time. Likewise, select a report from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.
Selected Destination	Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. You can select multiple agencies from the list of agencies such that the report can be submitted to multiple agencies at the same time. Likewise, select a report from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.
Ingredient	Automatically displays the Ingredient as provided in the Subject of Report dialog box. You can choose whether to view these field or not. Check the checkbox displayed with this field to hide or view it.
Trade Name	Automatically displays the Trade Name(s) as provided in the Subject of Report dialog box. Multiple trade names are also displayed together, separated by commas. You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.
International Birth Date	Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product. You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.
Print all configuration criteria on separate cover page	Mark this box to print out the configuration of this report when the report is printed. This is only available when PDF option is selected during printing.
Print page numbers on reports	When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations. If this checkbox is not checked, the following occur. The Include Periodic Page Numbering on CIOMS reports option on the PSUR Summary Tabulations CIOMS Reports section is grayed out and inactive. The Use Periodic Numbering on the reports option in PSUR Summary Tabulations FDA PSUR section is grayed out and inactive. The Additional Separate Page Numbering for UD Summaries in the PSUR UD Summaries tab is grayed out and inactive. The system removes all existing report page numbering and the option to check page number checkboxes on the report configuration tabs are grayed out and inactive.
Allow access to report cases through Hit List	When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.