Add Applications

To manage applications and associated submissions, you must add them from the repository. Use the Add Application window to add and register one or more applications in the system.

1. In the administrator console, click Add Application.
   Available repositories are listed.
2. Select the repository that contains the application you want to add.
   • All applications and associated submissions from the selected repository are displayed in the Applications section.
   • Selecting Show Application Type displays the application type in the Applications section. (To improve performance when navigating the folder hierarchy, it is recommended that you avoid using the option Show Application Type for repositories containing a large number of submissions). To display the application type by default, the value of the property tag displayApplicationType in the config.xml must be set to true true.
3. Select the application from the list of applications that appears for the selected repository. Use the Refresh button at the bottom of the window to refresh the applications and collapses the appropriate folders. When you expand the folders again, the Add Application window includes all changes.
   The submissions associated with a selected application appear in the Submissions section.
4. Select the submissions for the application that you want to register. You can choose all submissions or specific submissions.

   Action	Option
   To choose all submissions:	Select the check box next to Submission Number.
   To choose specific submissions:	Select the check boxes that appear next to the applicable submissions. Note: Submission registration is a Calyx RIM Viewing requirement. Registering your submissions can be done manually or automatically, and enables viewing of the submissions.

5. Click Next.
   The application details appear in the Application Information section.
6. Modify the editable information for the application.
7. Specify an Active or Inactive status for the application.
8. Select the appropriate value under Submission Status.
   • Selecting the submission status in the user interface will override the default status value that may have been defined by the defaultSubmissionStatus property tag in the config.xml file.
   • An application cannot be registered if the status of a submission within it is set to inactive in the defaultsubmissionstatus property tag of the config.xml file.
   • If Calyx RIM Viewing is configured to update the submission status value from Calyx RIM, the submission status value updated in Calyx RIM will be assigned to the submission.
9. Select the following options, as applicable:

   Option	Description
   Automatically Register Updated Submissions	When selected, the system automatically registers the updated submissions. Automatic registration occurs when the index.xml file is updated. This typically occurs when there are changes to the existing submission.
   Automatically Index Updated Submissions	This option is enabled only when the option Automatically Register Updated Submissions is selected. When selected, the system will automatically index any updated submissions.
   Automatically Register New Submissions	Automatically registers new submissions.
   Automatically Index New Submissions	This option is enabled only when the option Automatically Register New Submissions is selected. When selected, the system automatically indexes any new submissions.

   The auto register and auto index features help to avoid indexing and registering functionality conflicts. These features are effective in both single or multiple server environments. To use these features, settings must be modified in the config.xml file. For details, contact your administrator.

   The Automatically Register feature is not intended for registering a large number of submissions to an application. In this scenario, Calyx recommends selecting all of the submissions to register when adding the application (step 4).

10. To set comment-related permissions for the selected application, select the roles in the Distribution List.
    The Distribution List is used to manage the distribution of e-mails associated with the comments. Select the user roles that you want to send notifications to when comments are added or updated for the application.
11. To restrict printing of the TOC at the application level, select the option Restrict Printing of Application.
    Note: This option is displayed only when adding eCTD applications.

    To restrict printing at the submission level, skip this level and use the option in step 14.
12. The submissions for the selected application in the previous window appear under the Submissions section. To display the submission details, select View.
    This includes submission and metadata information extracted from the submission’s XML backbone.
13. If applicable, enter any remarks for the submission and/or select the date.
14. If printing of the application is not restricted (step 11), you can impose printing restrictions on individual eCTD formatted submissions by selecting the appropriate check boxes under Restrict Printing. To impose printing restriction on all the submissions, select the check box next to Restrict Printing.
15. Select the respective check boxes to index the documents within the submission.
16. To change any selection in the previous window, select Back.
17. To register the submission, click Register.
    The application is added and the submission is registered.

    Note: Always use the refresh button at the bottom of the application to view the changes after the operation. Avoid using the browser refresh button.