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.
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.
Parent topic: Configuring Letters