Field Descriptions

The following table describes the fields associated with this section.

Field or Control Name	Description
Name	Enables you to specify the name of the letter as it will appear in the Letters menu.
Name (J)	Enables you to specify the Japanese name of the letter as it will appear in the Letters menu.
Edit Template	Enables you to open the letter (template) for editing. Use only WordPad for editing letter templates.
Regulatory Cover Letter	Enables you to indicate whether this letter template should appear in the Regulatory Rules dialog Cover letter drop-down list box. The available options are: No, Yes – RTF Format, and Yes – PDF Format.
Schedule - Letter	Enables you to enter the number of days (from the receipt date) when the letter will be due.
Schedule - Action	The Action field enables the Administrator to specify the number of days (from the current date) after which the Action Item for following up on this letter will be due.
Sites	Argus Console provides the ability to configure letters to user sites. Enables users to select single or multiple sites for that letter. The system will only allow users to see letters that are configured to their site.
Action Items	The action items list is a drop-down list of action item codes from the Action Type List Maintenance.
Return Email Address	Enables you to enter a default email address where the mails will be sent. This address is displayed by default in the Activities tab of the Case Form.
Advanced Condition	Enables you to configure Advanced Conditions. If the case matches with the Advanced Condition, the configured letter is scheduled for the case.

Use the following procedure to configure letters.

1. Click the Letter Configuration folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.
2. Click the Name (or row), to view the details associated with that letter. The details appear in the Modify Letter Configuration section.
3. Use the Letter Configuration Filter to make your search specific to a letter. The filtering criterion is essential as it helps you to search for specific items.
4. Select the appropriate Field as the filtering criteria from the drop-down list.
5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.
6. Enter the search criteria in Value.
7. Click Filter to apply the selected criteria.
8. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new letter.

   • Use Copy to make an editable copy of an existing letter.
   • Use Delete to delete an existing letter.
9. Click Select to specify the path of the letter template to be used.

   Tip:

   Click Edit Template to save the existent template on to your local drive of the system.

   You can edit this template and repeat the step listed above, to ensure that the updated template is used for letters.

10. Enter the name of the letter, as it will appear, in the Letters Menu section in Enter a new item.
11. Click Add or Delete to configure letter to the user Sites.
12. Select the Action Item from the drop-down list box. The action items list is a drop-down list of action item codes, from the Action Type List Maintenance.
13. Configure the Advanced Condition for the case.
14. Enter the Schedule (days)-Letter. This is the number of days from the receipt date when the letter is due.
15. Enter the Schedule (days)-Action. This is the number of days from the current date, after which the Action Item for the follow up on this letter will be due.
16. Enable the Regulatory Cover Letter option to indicate whether this letter template should appear in the Regulatory Rules dialog.
17. Enter the default e-mail address in Return Email Address.
18. Click Save to save the changes made for this section.

Letter Placeholder for the IND Cover Letter

• You can define a placeholder for the IND_SIMILAR_EVENTS table. The system uses data from this table to populate the Case Number, Protocol Number, Subject ID, and Adverse Event terms for previously submitted cases reporting the same events.
• If no reports were submitted, the system prints None Submitted instead of the table.

  The placeholder only prints this information when it is used in the cover letter for the Regulatory Report. The system uses the license associated with the scheduled report to track other cases where the same product license was previously submitted for the same events in the current case.