Splitting Regulatory Objectives (RIM Registrations)

When changes are bundled, Health Authorities will sometimes reject specific changes or your organization will decide not to pursue some activities. The splitting wizard helps users to split the unapproved changes from the approved changes, helping to ensure global traceability of approval status.

Note: This feature is only available on RIM Registrations Vaults and must be configured before use. For details, see Configuring Bundling & Splitting.

How to Split Regulatory Objectives

To split bundled regulatory objectives:

Navigate to Applications > Regulatory Objectives and locate the regulatory objective you wish to split.
From the Actions menu on that objective, select Split Regulatory Objectives. Note that this may be labeled differently depending on your Vault’s configuration. If the action does not appear for specific activities, the activity is not in an allowed lifecycle state or your access is restricted by Action Level Security.
On the Define Regulatory Objective page, enter a Name for the new regulatory objective and select an existing Application. Then, select the applications to relate to the new Regulatory Objective record. Click Next.
On the Select Relationships page, choose the relationship type that you want to split from the existing submission. Click Next.
On the Define Relationships page, choose the specific relationships that you want to split from the existing submission. Click Next.
On the Select Registrations page, choose the registrations that are affected by splitting the regulatory objective. If you want to remove the relationships between the source Regulatory Objective record and the registrations you chose, select the checkbox above the grid. Click Next.
On the Define Submissions page, set the Create new Submission record checkbox to create a new record, and enter details for your new submission: Type of Submission, Submission Name, and Submission Type. Application Number is automatically selected based on the selection for the new regulatory objective. If you don’t want to create a submission, click Next.
On the Select Activities page, you will see a filtered list of activities that are related to the initial regulatory objective. Select the activities that you want to associate with the new regulatory objective. When you complete the wizard, Vault will update the Related Submission and Regulatory Objective fields on the Activity records you select.
Optional: Select the Create a new activity record for every activity selected above to track the split data checkbox at the top of the page. This allows Vault to create copies of the selected activities and associate them to the new regulatory objective rather than updating the existing Activity records.
Click Next to proceed.
On the Summary page, review the changes that your split action will make. If your selections are correct, click Finish. If changes are needed, click Back or use the steps listed in the left panel to click through past steps.
When the split process is complete, Vault sends you a notification. From the Notifications page or your email, you can download the CSV results file to review and confirm that the correct actions occurred.

After you run the splitting wizard, you can’t restart the wizard from the same Regulatory Objective record until processing is complete. This prevents Vault from inadvertently creating duplicate records.

Note: If your organization tracks labeling Activities for cross-functional Events using dependencies, Vault sets the field on target Activity records with the same Local Labeling Impact value as the source Activity record, and does not display the field in the wizard. To capture a value for the Local Labeling Impact, allow Vault to create the target Activity record, then edit and re-save the new record with the desired Local Labeling Impact.

Working in the Splitting Grids

The splitting wizard includes grid panes that allow you to easily find and select the records you need. Within the grid panes on these pages, you can:

Drag to adjust column width and row height.
Select Edit Columns from the Actions menu to update the columns in the grid.
Apply or remove filters.
Use the search bar to locate specific records.
Use the checkboxes to select or deselect individual records.
On pages that allow you to select multiple records, use Select All to select all available records.

Note that when you search or apply filters after you select records in the grid, the records remain selected even if they don’t match the search or filter results. The total count of currently-selected records appears above the grid.

Audit Trail

When you split bundled regulatory objectives, Vault includes each change made in the impacted object record’s audit trail.

Related Permissions

To use the spitting wizard, users must be assigned a permission set with the below permissions.

Additionally:

Users must be assigned the appropriate lifecycle role permissions to edit the Regulatory Objective record from which they launch the bundling wizard.
Users must have Execute access for both the Bundle Activities and Bundle Regulatory Objectives actions when your Vault’s Activity and Regulatory Objective lifecycles use Atomic Security for actions.

Permission Label	Permission
Objects: Activity	Read, Edit
Objects: Registration: [all relevant object types]	Read
Objects: Regulatory Objective: [all relevant object types]	Read, Create, Edit
Objects: Related Submission: Related Submission	Read
Objects: Submission: [all relevant object types]	Read, Create, Edit