Vault provides wizards that allow you to bundle multiple Activity or Regulatory Objective records into logical groups for future submission to Health Authorities. You can also split bundled activities and regulatory objectives to create separate submissions and new activities and regulatory objectives. These wizards ensure that related records are updated when bundling or splitting occurs, reducing the risk that users overlook update tasks and headquarters loses traceability.

The bundling wizards are particularly useful when an organization initiates changes at the headquarters level that affect country-level teams. The country-level teams can bundle multiple global activities along with local changes to reduce the overhead of multiple submissions.

About the Bundling Actions

You start the bundling process from the Actions menu on an Activity record or a Regulatory Objective record. The Bundle Activities or Bundle Regulatory Objective actions may have different labels depending on your Vault’s configuration. If either action doesn’t appear for specific records, the record is not in an allowed lifecycle state, or your access is restricted by Action Level Security.

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

How to Bundle Activities

To bundle multiple activities and create new submissions and regulatory objectives:

  1. Navigate to Registrations > Activities and locate one activity that you want to include in the bundle.
  2. From the Actions menu on the Activity record, select Bundle Activities.
  3. On the Select Activities page, use the checkboxes to select the activities that you wish to bundle into a single submission. Depending on your Admin’s configuration, the list may automatically filter for the allowed lifecycle states. Your Admin may have set up default filters, which you can modify or remove as needed.
  4. On the Select Relationships page, Vault shows a list of relationship types for the Event object and selects the available types automatically. You can use the checkboxes to deselect the relationship types that you don’t want to copy forward to the bundle’s regulatory objectives and submission. In the next step, you’ll select the specific relationships to include.
  5. The Define Relationships page shows the join records for the relationship types you selected. Choose the specific items to copy as joins for the regulatory objectives and submission you are creating.
  6. On the Define Regulatory Objective page, you can choose to select an existing objective or create a new one. See details about this step below.
  7. On the Select Registrations page, Vault displays a list of all Registrations records that are associated with the activities you selected. Select the registrations to associate with the regulatory objective. You can apply filters to refine the list if needed.
  8. On the Define Submission page, you can choose to create the new submission for the bundled activities. See details about this step below. If you don’t want to create the submission, click Next.
  9. On the Summary page, review the changes that your bundling action will make. If your selections are correct, click Finish. If changes are needed, click Back to revisit past steps.

Defining the Regulatory Objective

On the Define Regulatory Objective page, you can choose to select an existing regulatory objective for the bundle or to create a new one. For either option, you can also deactivate regulatory objectives that are related to the activities in your bundle. To do this, select the Mark unused Regulatory Objectives as inactive checkbox and choose one or more records.

Selecting an Existing Regulatory Objective

If you choose to Select existing, you will see a list of available regulatory objectives. Depending on your Admin’s configuration, the list may automatically filter to only show regulatory objectives in allowed lifecycle states. Your Admin may have set up default filters, which you can modify or remove as needed. Use the checkboxes to select a regulatory objective. Click Next.

Creating a New Regulatory Objective

To create a new regulatory objective for the bundle:

  1. In the Define Regulatory Objective field, select Create new.
  2. Select a Regulatory Objective Type.
  3. Enter a Name for the new record.
  4. Select the Application record to which the regulatory objective will apply.
  5. Fill in any other required fields.
  6. Click Next.

How to Bundle Regulatory Objectives

To bundle multiple regulatory objectives into one submission:

  1. Navigate to Applications > Regulatory Objectives and locate one record that you want to include in the bundle.
  2. From the Actions menu on the Regulatory Objective record, select Bundle Regulatory Objectives.
  3. On the Select Regulatory Objectives page, use the checkboxes to select the records that you wish to bundle into a single submission. By default, Vault selects all regulatory objectives in an allowed lifecycle state that have the same application as the initial Regulatory Objective record.
  4. Optional: Set the Select Additional Regulatory Objectives checkbox to select more records as needed. Depending on your Admin’s configuration, the list may automatically filter for the allowed lifecycle states. Your Admin may have set up default filters, which you can modify or remove as needed.
  5. On the Define Regulatory Objectives page, you can choose to consolidate any regulatory objectives with the same application into a single Regulatory Objective record. See details about this step below. If you don’t want to consolidate, select Do not combine regulatory objective records and click Next to proceed.
  6. On the Select Activities page, use the checkboxes to select the activities that you wish to include in the bundle. Under Suggested Activities, Vault automatically selects all activities that reference the regulatory objectives you selected on the first page. If you deselect any suggested activities, Vault clears the values in the Submission and Regulatory Objective fields on those records.
  7. Optional: Set the Select Additional Activities checkbox to see all records that reference the same applications as your selected regulatory objectives. Depending on your Admin’s configuration, the list may automatically filter for the allowed lifecycle states. Your Admin may have set up default filters, which you can modify or remove as needed.
  8. If you selected activities, you’ll see the Select Relationships page next. On this page, Vault shows a list of relationship types for the Event records related to your selected Activities. Select the relationship types that you want to copy forward to the bundle’s regulatory objectives. In the next step, you’ll select the specific relationships to include.
  9. If you selected relationships, you’ll see the Define Relationships page. On this page, Vault shows join records for each selected relationship type. Choose the specific items to copy as joins for the regulatory objectives.
  10. On the Define Submission page, you choose to create the new submission for the bundled regulatory objectives. See details about this step below. If you don’t want to create the submission, click Next.
  11. On the Summary page, review the changes that your bundling action will make. If your selections are correct, click Finish. If changes are needed, click Back to revisit past steps.

Defining Regulatory Objectives

To consolidate regulatory objectives for each application:

  1. Select Consolidate Regulatory Objective records per Application.
  2. Enter data in the required fields for the new Regulatory Objective records.
  3. Optional: To deactivate regulatory objectives that are related to your bundle, select the Mark unused regulatory objectives as inactive checkbox and choose one or more records.
  4. Click Next to proceed.

When you complete the wizard, Vault creates one (1) new Regulatory Objective record for each application with more than one selected regulatory objective.

Defining the Submission During Bundling

To create the new submission for the bundled activities or the bundled regulatory objectives:

  1. Select the Create new Submission record checkbox.
  2. Enter or select the submission details: Type of Submission, Submission Name, and Submission Type. Vault will automatically apply an Application Number based on the application associated with the regulatory objective.
  3. Optional: To use grouping for a US submission, select the Create Submission records for US Grouping checkbox and select one or more applications to copy the details for additional, grouped submissions.
  4. Optional: To use worksharing for an EU submission, select the Create Submission records for EU Worksharing checkbox and select one or more applications to copy the details for additional, grouped submissions.
  5. Optional: To deactivate submissions that are related to your bundled activities or regulatory objectives, select the Mark unused submissions as inactive checkbox and choose one or more submissions.
  6. Click Next to proceed.

Working in the Bundling Grids

The bundling wizards include 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.

Notifications

When the bundling process is complete, Vault sends you an email and a notification with a link to download the CSV results file. Review the file to confirm that the correct actions occurred.

Audit Trail

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

How to Split Activities & Regulatory Objectives

See Splitting Regulatory Objectives for detailed instructions on how to split regulatory objectives to create separate submissions and new regulatory objectives.

See Splitting Activities for detailed instructions on how to split activities to create separate submissions and new labeling concepts and regulatory objectives.

To use the bundling 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 access Regulatory Objective record actions in order to initiate a bundle action; ability to create new records and edit records through the wizard actions; needed for Regulatory Objective and Submission objects