Working with Submissions

After you’ve created an application, you can use that application to create submissions, which are then used to create submission content plans.

Diagram of Submissions and Content Plans created from an Application

To facilitate data integrity and ease data management across your submissions, RIM Basics: Submissions includes the Submission Wizard. You can use the Submission Wizard to create or update submissions within an application. The Submission Wizard can help Regulatory Operations Managers ensure that the related product family data is accurate and complete.

You can launch the Submission Wizard from an application and follow the Wizard’s steps as it walks you through the submission creation process.

Vault Admins and Submission Managers have access to the Applications and Submissions tabs, while Document Managers do not.

Viewing Submissions

Complete the following steps to view submissions:

  1. Navigate to the Submission Mgmt > Submissions tab and click All Submissions in the left panel to view a list of submissions.
  2. Use the Filters in the left panel to filter the submission list to help you locate the submissions you want to view.
  3. Click the Submission Name of the submission you want to view. Vault opens the submission in the Submissions tab and displays its details, relationships, lifecycle status, and more.
  4. Click a submission section in the left panel to navigate to that section and view additional details.

Creating Submissions

Use the Submission Wizard to create a submission from an application. When you create a submission, Vault assigns it the Planned status.

Complete the following steps to create a submission for an application:

  1. Navigate to the Submission Mgmt > Applications tab and click the Application Name to open the application for which you want to create a submission.
  2. From the All Actions menu, select Submission Wizard. The Start section of the Submission Wizard is displayed.
  3. From the Submission drop-down, select Create Submission. The Create Submission dialog is displayed.
  4. Enter a Submission Name.
  5. Select a Submission Type based on the selected application type.
  6. Optional: Select a Submission Subtype based on the selected submission type.
  7. Optional: Select the Dossier Format.
  8. Optional: Enter a Submission Description.
  9. Optional: Enter a Planned Submission Date.
  10. Optional: Enter a Sequence ID. For an eCTD submission, enter the sequence number. For a non-eCTD submission, enter the submission name.
  11. Enter any additional optional information as needed.
  12. Click Save. The new submission is displayed as selected from the Submission drop-down on the Start Page of the Submission Wizard.
  13. Click the checkbox for each Relationship in the application that you want to include in the submission. Click the Select All checkbox to select all relationships.
  14. Click Next to save the information and start the Define Relationships section of the Submission Wizard.
  15. For each relationship type selected on the Start page, click the checkbox of the specific relationship you want to add to the submission and click Next. When you have added the last relationship, the Summary section of the Submission Wizard is displayed.
  16. Review the submission information on the Summary page. If the information is incorrect, click Back to return to a previous page and update the submission information. If the information is correct, click Finish. A notification is displayed to indicate that the Submission Wizard is running and creating the submission, and Vault displays the Application page for the application you used to create the submission.
  17. Once you receive the Submission Wizard notification, click the Notifications bell icon to open the Notifications panel.
  18. Click Show More for the Submission Wizard notification to review the status of the submission.
  19. Click the Submission Name on the Application page to open the submission in the Submissions tab in the Submission Management tab collection.

Editing Submissions

Complete the following steps to edit a submission:

  1. Navigate to the Submission Mgmt > Submissions tab and click the Submission Name of the submission you want to edit.
  2. On the Submissions page for the submission, select Edit from the All Actions menu. Vault makes the fields in the Submission Details sections available to edit.
  3. Edit the information as needed and click Save. Vault saves your updated information.
  4. To edit a submission relationship, navigate to the section of the relationship you want to edit.
  5. Select Edit from the Actions menu to the right of the relationship name.
  6. Edit the information you want to change and click Save. Vault saves the updated information.
  7. If you want to delete a relationship, select Delete from the Actions menu.
  8. In the Delete Record dialog, click Continue to confirm that you want to delete the relationship.

Changing Submission Statuses

When you first create a submission, its status is Planned. Once you use a submission to create a content plan, Vault automatically sets the submission’s status to In Progress, but you can manually change the status as needed.

To change a submission’s status, select the appropriate Change Status action from the Workflow Actions menu, then click Yes in the dialog to confirm that you want to change the status.

Submissions use the following statuses:

  • Planned: The submission is planned but work has not yet started. You can change a Planned submission to In Progress or Canceled.
  • In Progress: The submission is being actively worked on in preparation for submission to a health authority. You can change an In Progress submission to Planned, Archived, or Canceled.
  • Deferred: The submission has been deferred to a later date.
  • Archived: The submission has been archived. You can change an Archived submission back to In Progress.
  • Canceled: The submission has been canceled and is no longer applicable. You can change a Canceled submission back to Planned or In Progress.