Calyx RIM Publisher

Create a Major Update Submission

You can update an existing application for a new business objective or regulatory activity. When creating a major update submission, an event is created and you can create a sequence, if needed.
Note: To create a major update submission, an application must exist for the product family and associated country, and you must have the appropriate security permissions.
To create a major update submission:
  1. Click Wizards > Create Submission.
    The Create Submission wizard opens to the Choose Submission Type page.
  2. Click Major Update.
  3. Click Next.
    The Complete Submission Properties page appears.
  4. Enter the required information for creating an event.
    Creating a sequence is optional.
    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. If you change, the format, Calyx RIM will issue a message requesting confirmation that you accept the deviation from  the default sequence numbering format.
  5. Click Next to confirm your selections.
    The Create Submission Confirmation page appears.
  6. 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.
  7. Do one 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 10.
    • To return to previous pages to change your selections, click Back.
    • To cancel the submission entirely and return to the view from which you invoked the wizard, click Cancel.
  8. 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 link is available for SPT, ELP, and RDA 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.
    • To create an eCTD, click the second assembly link to start the eCTD wizard.
    • To return to the location where you invoked the Create Submission Wizard, click Finish.