Report Generation Usage Considerations

When building a report, consider the following:

• Only the owner of the periodic report can initiate the generate process.
• The owner can initiate the build process only after all sections of the periodic report have been marked Ready for Build.
• The Build button active if the Ready for Build check box on the Author tab is checked.
• When you click Build, the system compiles the report in the order on the Arrange tab.
  • The system converts all files to PDF (if not already PDF) and adds any required header, footers, and page numbers to the report.
  • The system displays a message box with the following message:

    Your Dossier report has been submitted to final build.

  • The system saves the current arrangement before it starts the Build process.
• The Build process does the following:
  • Merges all template sections into a single PDF file.
  • Ignores instructional comments.
• You cannot modify a periodic report while the Dossier build process is running, and the system disables the Modify and Print buttons until the build process is complete.
• The system prevents you from moving any section on the Arrange tab while the system is building the report. The Arrange section should be grayed out and you cannot move any sections of the report.
• Once the final build is completed, the system disables the Build button.
• If you make any changes on the Arrange tab and click Save after the build is successfully completed, the system displays the following message:

  Your dossier is already built. Saving any changes will require that you rebuild the dossier again. Are you sure you want to save these changes.

  If you click Yes, the system does the following:

  • Dismisses the message.
  • Removes the existing report.
  • Enables the Build button.
  • Disables the View PDF button.
  • Disables the Publish button.

    If you click No, the system retains the existing report.

• Status Button
  • The system activates this button after you start the build process.
  • This button remains active once the build process is completed
  • If you click this button after the build process starts, the system displays the status of the build process in the standard report generation pop.
  • When you click Close on the status window, the system does the following:
    • Closes the status window.
    • Continues to generate the report.
  • The status window displays the progress of the build process.
• The system displays the following statuses, in order of occurrence:

  Dossier Report Generation Request Received

  • Status is followed by a date and time stamp for when this action kicked off the report in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43")

  Dossier Report Generation Started

  • The system displays a grayed out check mark until this process starts (picked up by AG Service)
  • Once AG Service picks up the process, the system displays a date and time stamp showing when this action started in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43")

  Report Converting Templates to PDF

  • The system displays a grayed out checkmark until this process starts.
  • While the process is in progress, the system displays "Processing…"
  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.
  • Processing time displays as follows: "(completed in xx min.)"

  Merging Sections before Table of Contents

  • The system displays a grayed out checkmark until this process starts.
  • While the process is in progress, the system displays "Processing…"
  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.
  • Processing time displays as follows: "(completed in xx min.)"

  Merging Sections after Table of Contents

  • The system displays a grayed out checkmark until this process starts.
  • While the process is in progress, the system displays "Processing…"
  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.
  • Processing time displays as follows: "(completed in xx min.)"

  Creating Table Of Contents and Bookmarks

  • The system displays a grayed out checkmark until this process starts.
  • While the process is in progress, the system displays "Processing…"
  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.
  • Processing time displays as follows: "(completed in xx min.)"

  Creating Final Dossier

  • The system displays a grayed out checkmark until this process starts.
  • While the process is in progress, the system displays "Processing…"
  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.
  • Processing time displays as follows: "(completed in xx min.)"

  Dossier Report Generation Completed

  • A grayed out checkmark is displayed until this process is started
  • Once the process is complete, the system displays a date and time stamp showing when this action started in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43"). Errors in the build process are logged into the Safety Error Log.
  • The system displays a grayed out check mark until this process starts (picked up by AG Service)
• If an error occurs during any of the build process, a status box displays the following error message:

  Failure, please refer to the Argus Safety Error Log for details.

  Any final build error(s) are recorded in the Oracle Argus Safety error log.

  When an error occurs, the system destroys any compiled documents. You must restart the process

View PDF Button

• Once the final build process is completed, the system enables the View PDF button.
• Click this button to display the report.

Publish PDF Button

• Once the final build process is completed, the system enables the Publish button.
• If you make changes to the report, the system disables this button until a new build process is completed.

If you make any changes in the Arrange window (i.e., move a report section up or down or add or remove a report section) after the build is completed, the following occurs:

• The system displays the following message:

  The final dossier has been generated. Making changes now will require the report to be rebuilt. Are you sure you want to make changes?" Options OK or Cancel.

• If you click OK, the system does the following:
  • Disables the View PDF button.
  • Disables the Status button.
  • Disables the Publish button.
  • Enables the Build button.
• If you click Cancel, the system closes the message box and cancels the change action.

When the system opens the Argus Dossier Template window, only the following are enabled. All other buttons, icons, or links are disabled.

Status Button

Author Tab Section Links

• Template Section Links
• Generated Report Links
• Additional Content Links
• Header/Footer Links

Author Tab Comments Icon

• The comments are read-only, and you cannot enter new comments for the Templates Comment icon and the Header and Footer Comments icon.

Arrange Tab

• Arrange Tab Section Links including links to templates, generated reports, and additional content links
• Removed content links.
• View PDF Button

Per the regulation "Guidance for Industry, Providing Regulatory Submissions in Electronic Format - General Considerations" (1999), "the initial page of the paper document should be numbered page 1."

• Set the common profile to "Starting from the First Page" so that the first page of the report is page 1, no matter where the table of contents is placed on the Dossier Arrange tab.
• If page numbering is turned off, no page number prints. However, the first page of the report is considered page 1.