When changes are bundled, it is possible that Health Authorities will reject some changes, or that pending labeling changes must be deferred and tracked separately from completed ones. The splitting wizard helps users to separate the unapproved or incomplete changes from the approved or completed changes, helping to ensure global traceability of their 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 Activities
To split activities:
- Navigate to Registrations > Activities and locate the activity you wish to split.
- From the Actions menu on that activity, select Start Splitting Process. Depending on your Vault’s configuration, the action may be labeled differently. 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 record definition page for Activities, enter a Name for the new activity. Depending on your Vault’s configuration, this field may be pre-populated and not editable. Then, select or remove the registrations to relate to the new Activity record. Click Next.
- Optional: On the record definition page for Activity Labeling Concepts, you will see a filtered list of Labeling Concepts that are related to the initial activity. Select the labeling concepts you want to associate with the new activity. When you complete the wizard, Vault will inactivate the records you select and copy the Local Concept Disposition to the new labeling concepts. Click Next.
- On the record definition page for Regulatory Objectives, set the Select Existing option to choose an existing Regulatory Objective, then click Next. You can also select Create New to create a new record, then enter the required details. Depending on your Vault’s configuration, the Name field may be pre-populated and uneditable, and you may have the option to set Mark unused Regulatory Objectives as inactive to select Regulatory Objectives related to the Application.
- On the record definition page for Submissions, set the Select Existing option to choose an existing Submission, then click Next. You can also select Create New to create a new record, then enter the required details. Application Number is automatically selected based on the selection for the new activity. If enabled in your Vault, you can also set Mark unused Submissions as inactive to select Submissions related to the Application.
- On the Select Relationships page, choose the relationship type that you want to split from the existing regulatory objective. Click Next.
- On the Define Relationships page, choose the specific relationships that you want to split from the existing regulatory objective. Click Next.
- 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 Activity 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.
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 activities, Vault includes each change made in the impacted object record’s audit trail.
Related Permissions
To use the spitting wizard, you’ll need:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Object: Activity: Edit | Ability to access Activity record actions in order to initiate a bundle action; ability to modify an Activity record during a split action |
| Security Profile | Object: Regulatory Objective, Submission: Create, Edit | Ability to create new records and edit records through the wizard actions; needed for Regulatory Objective and Submission objects |
| Security Profile | Object: Base Regulatory Objective, Base Submission, Base Related Submission: Read | Ability to access the splitting wizard; needed for Base Regulatory Objective, Base Submission, and Base Related Submission objects |
Note: If your organization has set up Action Level Security for the Start Splitting Process action on the Activity object, you must have the required access for this action.