Calyx RIM Publisher

Create an Initial Application Submission

Use the Create Submission wizard to create an initial application submission for a specific country, set of countries, or region. When an initial application is created, the event-country status schedules will be created for each country included in the application.
Note: The wizard for creating a submission for an initial application does not use the default Application Type and Procedure Type values for the selected Reviewing Country. These defaults are for Copying Applications and the Global Project Planning (GPP) wizard.
To create an initial application submission:
  1. Select Wizards > Create Submission.
    The Create Submission wizard opens to the Choose Submission Type page.
  2. Click Initial Application.
  3. Click Next.
    The Complete Submission Properties (application) page appears.
  4. Enter the application properties for the submission. 
  5. Click Next. The Complete Submission Properties (event/sequence) page appears.
  6. On the Complete Submission Properties (event/sequence) page, do any of the following:
    • To create an event, enter an Event Code, Keywords and Description. If no entry is made to the event-related fields, the event will still be created with default values.
    • To use a timeline/event plan to create the event, select a Timeline/Event Plan from the drop-down list.
    • To change the event type, select the value from Event Type drop-down list. The New Application value is selected by default.
    • To create a sequence, select the Create sequence? check box.
    Note: If you choose to create a sequence, you can change the default sequence numbering of a P followed by four digits. This numbering scheme is the format recommended for an eCTD submission. The sequence code must be unique within the application. If you change default numbering format, the wizard will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.
  7. Click Next.
    The Create Submission Confirmation page opens, confirming the actions that will be performed based on your selections.
  8. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature and SSO are enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
    When electronic signature is enabled and SSO is disabled
    1. Select a reason and enter comments for the reason.
    2. Enter user ID and password and click Next.
  9. On the Create Submission Confirmation page, do any of the following:
    • To confirm your selections, click Next. The Create Submission Summary page opens, listing the created items. Additional items you can add to the submission may also be listed. Proceed to step 9.
    • To return to the previous pages to change your selections, click Back. 
    • To cancel the submission entirely and return to the view form which you invoked the wizard, click Cancel.
  10. On the Create Submission Summary page, do any of the following:
    • To view the created event, click the event link.
    • If you created a sequence and want to view it, click the sequence link
    • To update a PDS associated with the event, click the PDS link. This option is available for PDM users.
    • To create an assembly, click the first assembly link. This options is available for SPT users. If you create an assembly from an existing template, assembly, or view, to find an assembly, click Browse and use the Search Assembly wizard. See Searching for an Assembly.
    • To create an eCTD, click the second assembly link to start the Create eCTD wizard.
    • To return to the location from which you invoked the Create Submission wizard, click Finish.