Author Tab Usage Considerations

When using the Author tab, consider the following:

• The system disables the Generation Status button until you initiate the report build process.
• The screen displays all periodic report configuration elements in sections on the tab.
  • Templates Section

    This section lists all sections of the template as configured in previous steps

    The Template name is a hyperlink. When you click the template name, the application opens the raw template from the database.

    This section displays all the pre configured templates you added when you created the report.

    The templates are listed in the order they were in when the report was created.

    Click the report section link to view the template file.

    The application displays a minimum of six rows. If there are more rows, a scroll bar is available. The scroll bars appears as necessary

  • Generated Reports Section

    The application displays the report sections ascending order by Type and then by Section.

    Click the report name to view the latest version of a report. The system displays the report (in PDF format) in a separate window.

    Click the report section link to view the section report.

    The system displays a minimum of six (6) rows. If there are more than six (6) rows, the system displays a scroll bar.

    Generated report types are: PSUR, CTPR, NDA, and IND. The following table lists the report names for each report type.

    Report Type	Report Names
    PSUR	Report Configuration Line Listing Index of Cases in Line Listing Summary of Cases missing assessments Line Listing Tabulation Summary of Unlocked Cases CIOMS reports Cumulative Summary FDA - Adverse Event Summary FDA - Domestic Consumer Report FDA - MedWatch forms CDA or CL based on cases in Line Listing (*) CDA based on all cases (*) CDA or CL based on date range
    CTPR	Report Configuration Line Listing Index of Cases in Line Listing Summary of Cases missing assessments Count of Cases per Report Type Event Count per Study Drug (1) Event Count per Study Drug (2) Line Listing Tabulation Summary of Unlocked Cases CIOMS reports Cumulative Summary FDA - Adverse Event Summary FDA - Domestic Consumer Report FDA - MedWatch forms CDA or CL based on cases in Line Listing (*) CDA based on all cases (*) CDA or CL based on date range
    NDA	Report Configuration Tab 1: MW or VAERS forms Tab 2: Index of MW or VAERS forms Tab 3 Part 1: Line listing of 15-day reports submitted Tab 3 Part 2: Tabulation by SOC of all events submitted Tab 3 Part 3: Cases sent to FDA under a different NDA Summary of Cases missing assessments Summary of Unlocked Cases List of Nullified 15-day cases Custom Case Summary Tabulation CDA based on cases in Line Listing (*) CDA based on all cases (*) Case Count Summary
    IND	Report Configuration Line Listing of Cases Line Listing of Death Cases CDA based on cases in Line Listing (*) CDA based on all cases (*)

• Additional Content Section

  You can upload additional information to attach to the report.

  • You can only upload the following file types: .PDF, .DOC, and .DOCX.
  • If you try to upload another file type, the system displays the following error message:

    Your file has not been uploaded. File type must be .pdf, .doc, or .docx.

  • When you click Add, the system opens an upload pop-up box.
  • You must enter a description of the file you are uploading. If you fail to enter a description and click OK, the system displays the following error message:

    You must enter a description for the file you are uploading.

  • The maximum size of the uploaded file is 30 MB.

  The names in the Additional Content section are links. Click the link to open the file.

  If you select a row and click Delete, the system displays a confirmation dialog box with the following message:

  Are you sure you want to delete the highlighted Row.

  • Click Yes to delete the row.
  • Click No to dismiss the dialog box without deleting the row.

    The system displays a minimum of four (4) rows in the section. A scroll bar displays if there are more than four (4) rows.

General Usage Information

• Click the collapse and expand icons to collapse/expand each section.
• The system highlights a selected row.

An Author button is available for each template.

• The system enables the Author button to all user roles that have access to Oracle Argus Dossier.
• Click the Author button to open the Questions dialog.
• All users can view all questions; however, only Authors and Owners can change answers.

Only a user assigned an Author role can execute individual templates.

• The Author operation guides you through all questions (as defined in the template and processed during upload). You are expected to answer the questions.
• After the user clicks Draft or Final, the system generates a Microsoft Word document (.DOC/.DOCX format) that contains the processed content and narratives.
• Once the user clicks Final, the system generates the final version of the template and allows the Author user to check the Ready for Review check box.

The system enables the Ready for Review and Ready for Build checkboxes and the Check In and Check Out buttons when a Template is Final.

When a template is Final, the system enables the Ready for Review check box.

• Only the template Reviewer and the report Owner can check this check box.
• Once this box is checked, the system does the following:
  • Enables the Ready for Build option.
  • Prevents you from generating a final template.
  • Disables the Ready for Review check box. Once checked, this check box cannot be unchecked.

The system enables the Ready to Build option when you select Ready for Review.

• Only the Author or Owner can check the Ready for Build option.
• You can uncheck this option after it has been checked.

The system enables the Check In and Check Out buttons when you check the Ready for Review option.

• Click the Check Out button to open the Check Out dialog box.
• When a document is checked out, the system hides the Check Out button.
• The system displays the Check In button only if the final template has been checked out.
• Click the Check In button to open the Check In dialog.
• The Final template can be checked out by one user at a time.
• Only the user who checked the document out can check it in.

The system displays the Last Check in Comments in a text box on the screen for each template. Click the Zoom icon to open the check in comments in a popup dialog.

When all template sections and Header and Footer sections are checked, the Owner can build the report. The build process does the following:

• Merges all template sections into one.
• Creates a comprehensive .doc or .docx file.
• Saves the final document in the database and opens it on the screen.
• Enables all users (if the build was successful) to check-out the document and edit it manually.
• Enables users to check-in this document after check-out.

The system enables the Build button only if the following are true:

• The user is the owner of the periodic report.
• All the templates have been marked as Ready for Build.

If Documentum is configured, AG Services picks up the built file and saves it in Documentum.

• If Documentum is not configured, the file is marked not submitted.
• The file is saved in .PDF format.