After you’ve created an application, you can use that application to create regulatory objectives, which are then used to track one or more submissions.

To facilitate data integrity and ease data management across your submissions, RIM Basics includes the Submission Wizard. You can use the Submission Wizard to create or update regulatory objectives 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 regulatory objective creation process.

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

Viewing Regulatory Objectives

Complete the following steps to view Regulatory Objectives:

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

Creating Regulatory Objectives

Complete the following steps to create a Regulatory Objective:

  1. In Submission Mgmt > Applications, click the Application you want to create a Regulatory Objective for.
  2. Click the upper right hand corner, click All Actions menu, then click + Submission Wizard.
  3. Enter a name for the Submission.
  4. From the Regulatory Objective drop-down, select + Create Regulatory Objective. The Create Regulatory Objective dialog is displayed.
  5. Enter a Name.
  6. Optional: Select a Regulatory Objective Type.
  7. Optional: Enter any additional Comments.
  8. Optional: Enter an Initial Submission Date.
  9. Optional: Enter a Planned HA Response Date.
  10. Optional: Enter an Actual Decision Date.
  11. Optional: Enter a Planned Approval/Authorization Date.
  12. Click Save. The new Regulatory Objective will be displayed in the 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 regulatory objective and click Next. When you have added the last relationship, the Summary section of the Submission Wizard is displayed.
  16. Review the regulatory objective information on the Summary page. If the information is incorrect, click Back to return to a previous page and update the regulatory objective information. If the information is correct, click Finish. A notification is displayed to indicate that the Submission Wizard is running and creating the regulatory objective, and Vault displays the Application page for the application you used to create the regulatory objective.
  17. 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 regulatory objective.
  19. Click the Regulatory Objective name to access the regulatory objective details.

Editing Regulatory Objectives

Complete the following steps to edit a Regulatory Objective:

  1. Navigate to the Submission Mgmt > Regulatory Objectives tab and click the Name of the regulatory objective you want to edit.
  2. On the Regulatory Objective page for the regulatory objective, select Edit from the All Actions menu. Vault makes the fields in the Submission Details sections editable.
  3. Edit the information as needed and click Save. Vault saves your updated information.
  4. To edit a regulatory objective relationship, navigate to the section of the relationship you want to edit in the left panel.
  5. Click the Name of the item you want to edit, then click Edit from the All Actions menu.
  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 Regulatory Objectives Statuses

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

To change a regulatory objective’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.

Regulatory Objectives use the following statuses:

  • Planned: The regulatory objective is planned but work has not yet started. You can change a Planned regulatory objective to In Progress, Withdrawn, or On Hold.
  • In Progress: The regulatory objective is being actively worked on in preparation for submission to a health authority. You can change an In Progress regulatory objective to Planned, Withdrawn, or On Hold.
  • Withdrawn: The regulatory objective has been withdrawn and futher progress is not expected.
  • On Hold: The regulatory objective on hold for the near future, but is planned to begin at a later date. You can change an On Hold regulatory objective back to In Progress.