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, RIM Admins, and Submission Managers have access to the Applications and Submissions tabs, while Document Managers and Document Participants do not.
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.
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 You can change a Planned regulatory objective to In Progress, Withdrawn, or On Hold.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 You can change an In Progress regulatory objective to Planned, Withdrawn, or On Hold.
- Withdrawn: The regulatory objective has been withdrawn and futher progress is not expected.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.