Format

The system allows the definition of PSR reports for products. The purpose is to define a fixed set of PSR reports for PRIMARY AGENCY (the various regulatory authorities as optional) and then associate products with these reports. The PSRs can then be scheduled automatically.

PSR applies only for Japanese licenses.

• The system contains a configuration screen to define a PSR report. Go to Reports > Periodic Reports > PSR/ReSD reports. The following page is displayed.
  

PSR Main Window

• If the report is being currently opened by another for modification, the system displays the following message: The report which is selected is being used by XXXX and cannot be modified. where XXX is the full user name of the user has opened it.
• The labels and buttons related to the CSV files and FD validation reports are hidden in the Edit and View Report dialog box invoked for the PSR Report (Paper format), CSPR, and Seiyakukyo reports.
• The Create from Template button that is available on Argus E PSUR and CTPR section is not added for Japanese PSR, ReSD configuration.
• This page displays a list of the PSR reports stored in the system.
  • You can add a new report by clicking on the New Report button.
  • The Copy button makes a copy of an existing report:

    When you copy an existing PSR Report, all the configuration of the report including timeframe rows are copied.

    Report Name of new copy has copy of in front of the name.

    When the configuration is copied, the past dates in the schedule frequency, JAD, IBD, and Assigned date are also copied as read-only. The other sections of the copied configuration are editable.

    When you copy an existing non-submitted PSR report, all the configuration including timeframe rows are copied. As the original report is non-submitted, all the timeframe rows are retained as non-editable or editable as they were in the original PSR. The JAD, IBD, and Assigned Date become editable or non-editable depending upon if there are timeframe rows in the copied PSR which are non-editable.

  • The Modify button displays the report definition.
  • The Delete button allows you to delete a report after displaying the following confirmation message: Proceeding to Yes will remove the report configuration. Proceed?
  • Clicking Print, results in displaying a new dialog prior to report preview allowing you to select from several preview or direct export options: Word output.
• The Delete option is only available if there are no final reports generated for the Periodic Reports. The Delete option only hides the report from the list.
• In the recently executed Periodic Report section, a link is available for the last executed report only if the Report is still available on the Report Server.
• Clicking New or Modify in the above screen displays the PSR Configuration Window.
• Once the state of the report is changed to Submitted, you cannot update the configuration of that PSR. This is done by disabling the OK button. For example, when the state is un-submitted, the report is editable again. In addition, when the non-editable configuration is opened, the following warning message is displayed: This configuration is not modifiable because the status of this Periodic Safety Report is Submitted.

  When you click OK, this displays the Configuration window.

  When you click Cancel, the configuration window is not displayed.

• When the status of the report is Submitted, only the configuration page is printed.
• The Copy can be done any time while the configuration exists.

  When you create PSR after 2nd time, the new copy of the configuration is required. You can then modify the content to print the current PSR.

• Before saving the PSR configuration, Report Name, Primary Agency, Product Selection, and at least one time frame need to have a value entered.

  When these are not entered, the following messages are displayed: When Report Name is not entered:

  Report Name is not entered

  When Primary Agency is not entered:

  Primary Agency is not entered

  When selected product is not available:

  Product is not selected

  When At least one time frame is not entered:

  Investigation time frame is not configured

  The following message is displayed along with the above error:

  It is necessary to enter above information in order to save the configuration

• When Modify, Copy, Delete, or Print button is clicked without a selection of report, a pop-up is displayed to select a report.