After you receive notification from a Health Authority that your regulatory objective is approved, you can use a lifecycle user action to update registration data or to add or update related registered details records. Within the Manage Registered Details wizard, you can perform targeted data updates, either individually or in bulk, so changes impact only the intended registration records.
You can use the Manage Registered Details wizard to add or update registration information for drug products, medical devices, active substances, and manufacturing sites.
Note: This feature is only available on RIM Registrations Vaults. An Admin must configure this feature before you can use it.
About Registered Details
You can use the Manage Registered Details wizard to add or update the following registered details records:
- Registered Active Substance (
registered_active_ingredient__rim) - Registered Authorization
- Registered Clinical Study
- Registered Device Identifier
- Registered Inactive Ingredient
- Registered Indication
- Registered Nomenclature Code (
registered_product_classification__v) - Registered Organization (
registered_site_organization__v) - Registered Packaged Product (
registered_packaged_medicinal_product__v)(update only) - Registered Packaging
- Registered Packaging Characteristic
- Registered Product (
registered_drug_product__rim) - Registered Product Characteristic
- Registered Regulatory Text
- Registered Shelf Life or Condition (
registered_shelf_life_and_storage__v) - Registered Site Contact
- Registered Site Role
About the Use for Registrations Field
When configured by an Admin, the Use for Registrations Yes/No field allows your organization to specify which records Vault considers when creating registered details.
For example, you may want to exclude certain records when an Application Inactive Ingredient consolidated detail record for all manufacturers is included in the dossier. To prevent the wizard from creating a corresponding Registered Inactive Ingredient, you can check No for the field within the Application Inactive Ingredient record.
Depending on your Vault’s configuration, the Use for Registrations field can be used within the below Event, Application, Submission, and Regulatory Objective relationship detail records (for example, Event Product and Regulatory Objective Nonclinical Study):
- Product
- Active Substance
- Inactive Ingredient
- Indication
- Clinical Study
- Nonclinical Study
Using the Manage Registered Details Action
About the Manage Registered Details Action
You start the Manage Registered Details wizard from the Actions menu on a Regulatory Objective record. The Manage Registered Details action may have a different label depending on your Vault’s configuration. You may not be able to access this action if:
- There are no Registrations related to the Regulatory Objective
- The related Registrations do not have the Country field populated
- Your access is restricted based on your permission set or field-level security.
After you run the 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. You cannot manage registered details for impacted registrations that are part of an active verification workflow.
Starting the Manage Registered Details Wizard
To start the Manage Registered Details wizard:
- Navigate to the Regulatory Objective record.
- From the Actions menu, select Manage Registered Details. We recommend only updating registrations of the same object type, for example, Investigational Registrations.
- On the Registration Change Details page, select a Lifecycle State and populate any required fields. This defines the next lifecycle state for the Regulatory Objective record. Vault only displays and enforces conditional entry actions based on the data in the Regulatory Objective record at the time you start the Manage Registered Details wizard.
- Optional: If your Vault was created before the 18R3 release, review the selected Related Submissions and add or remove Submissions as needed. You can only use data from the selected Submissions to update or add registered details. You won’t see this option if your Vault is configured to use Regulatory Objective data rather than Submission data to update registration details.
- If your Vault is configured to use the registration verification workflow, review the workflow details. Depending on your Vault’s configuration, you may need to select the users or groups that will receive review tasks.
- In the Define Scope section, use the checkboxes to select the changes you want to make. Update Registration Fields or Lifecycle State lets you update Registration-level data, while Update Current Registered Details updates existing registered details records, and Add New Registered Details creates new registered details object records. When you add new details, Vault automatically selects all types with corresponding data based on the Regulatory Objective relationships. When you update existing details, you can select any available record type.
- Click Next.
- Continue through the wizard. The pages you see depend on your selections on the Registration Change Details page. See details below about working in the Registration Details page, the Registered Details pages, or the Add New Details page.
Working with Registration Details & Registered Details
If you selected Update Registration Fields or Lifecycle State in the Define Scope section, you see the Registration Details page, with all registrations related to the regulatory objective grouped by country. If you are updating existing registered details, you see one (1) Registered Details page for each registered detail type you selected, with existing records of each type grouped by country and registration.
Within the grid panes on these pages, you can:
- Click the arrow icons to expand a country and see all country-specific registrations and to expand a registration to see its related registered details.
- Drag to adjust column width and row height.
- Select Edit Columns from the Actions menu to update the columns in the grid. You cannot edit columns after you update fields or apply filters.
- Edit fields inline in the grid view; fields you’ve edited appear grey, but Vault doesn’t save any field updates until you complete the wizard.
- Use the filter icon (
) available in some columns to filter the results shown. Filtering is available for Picklist, Lifecycle State, and Object fields. Filtering is not supported for other field types. - Clear an applied filter by clicking the filter icon and then clicking Clear filter.
- Use the checkboxes to select or deselect individual records.
- Use the checkboxes next to each country to select all records for a country.
- Use the checkboxes next to each registration to select or deselect all its related registered details.
- Use Select All to select all countries and registrations. Select All is only available for lists of 1,000 records or less; if needed, you can use the filters to reduce the number of records in the grid. If you edit columns after selecting all records, Vault clears your selections.
- Use the Update Fields button to update fields on individual records or update fields in bulk. You can only update controlling fields and the Lifecycle State field from the Update Fields dialog.
Note: The fields you see in the grid and the order in which they appear depend on your Admin’s configuration for the Registration object and for each Registered Detail object. You cannot update in the Manage Registered Details wizard. Vault remembers your last column selections and reapplies them when you return to the page.
Adding New Details
If you are adding new registered details, you see the Add New Details page, with existing Registration records in a grid filtered by country. To add new details:
- Expand a country to see its Registration records.
- Optional: Use the filter () icons available in some columns to filter the records in the grid. To remove a filter, click the filter icon again and then click Clear filter. Filtering is available for Picklist, Lifecycle State, and Object fields. Filtering is not supported for other field types.
- Use the checkboxes or the Select All button to select the Registration records to which you want to add registered details. You can only add new details for one Registration object type at a time.
- Click Add New Details.
- In the dialog, Vault displays records for each applicable Registered Detail Type. Use the checkboxes or the Select All button to select the registered details you want to add. When adding new details, Vault can also copy custom field values to new registered details records if there is a matching field defined in the relevant Registered Detail Object.
- If necessary, select the object type for each of the Registered Detail Types.
- Select a Lifecycle State for each of the Registered Detail Types.
- Fill in any required fields.
- Click OK.
When you close the dialog, Vault displays an icon (
) next to the updated registrations to alert you of changes. Hover over the icon to view details. In the hovercard, you can click the View/Modify relationships link to open the dialog and update your selections. You can also click Clear New Details to clear changes for the selected records.
Completing Manage Registered Details
On the Confirmation page, review the details of the records you’re creating or updating and click Finish. The records that Vault creates or updates depend on the variables set throughout this process. See details about record creation when adding new details and updating existing details below.
Registration Verification
Your Vault may include a registration verification workflow that allows designated users to review each update to registration data before committing changes to your Vault. This ensures that records are not updated with incorrect or incomplete data.
When a verification workflow is configured, Vault does not create or update registration data until the workflow is complete. Vault updates the Regulatory Objective lifecycle state and associated fields immediately, even if your Vault uses a verification workflow. See Registration Verification for more information.
About Record Creation & Update
Field & Relationship Defaulting (Update Existing Details)
In addition to the fields you updated and lifecycle state changes you selected in the wizard, when you select Update Existing Details Vault updates the Regulatory Objective field on any updated records based on the Regulatory Objective or Submission from which you started the wizard.
Field & Relationship Defaulting (Add New Details)
Copying Custom Fields
When you select Add New Details, Vault can copy custom field values from the Regulatory Objective or Submission record to the corresponding registered details records, depending on your Admin’s configuration. Vault supports copying custom fields for Picklist, Object, Date, DateTime, Yes/No, Text, and Number field types. Copied custom field values appear on the Select Registered Details page of the Manage Registered Details wizard.
Creating Records
When using the Manage Registered Details wizard to add registered details records, Vault creates and populates them based on the Regulatory Objective data per the table below.
| Regulatory Objective** | Details on Regulatory Objective Record | Result |
| Registered Product |
Product*, Product Variant*, Manufacturer, Manufacturing Site Role, Site Product Type, Risk Class (device-only), Product Information URL (device-only), Medical Device Type (device-only), Use for UDI (device-only) |
*Not applicable for manufacturing site registrations. |
| Registered Active Substance | Active Substance, Manufacturer, Manufacturing Site Role, Site Product Type, Substance Classification (device-only), Use for DI (device-only) |
*Not applicable for manufacturing site registrations. |
| Registered Inactive Ingredient |
Inactive Ingredient, Manufacturer, Manufacturing Site Role, Site Product Type, |
For product, investigational, or active substance registrations, Vault adds Registered Inactive Ingredient records when the Inactive Ingredient is associated with the Product and Product Variant on any of that registration's Registered Product records, or if the Inactive Ingredient is associated with one or more of the components of any complex products on that registration's Registered Product records. *Not applicable to manufacturing site registrations. |
| Registered Indication | Indication, Orphan Designation, IDMP Full Indication Text, Indication Translation |
For product, investigational, or active substance registrations, Vault adds a Registered Indication record for all records you selected in wizard. *Not applicable for manufacturing site registrations. |
| Registered Packaging |
Packaging,Packaging Site, Shelf Life, Product*, Product Variant*,Finished Product Manufacturer, Site Product Type, Manufacturing Site Role, Finished Product Code, Packaging UDI-DI (device-only), DI Contained Within (device-only) |
*Not applicable for manufacturing site registrations. |
| Registered Clinical Study |
Clinical Study, Country, Site, Use for UDI (device-only) |
Note: For Countries with a study scope of Study, you can only create Registered Clinical Studies using the Create Registrations wizard. *Not applicable for product, active substance, or manufacturing site registrations. |
| Registered Product Classification |
For product or investigational registrations, Vault adds Product Classification records when the selected record has a Product and Product Variant and the values match the Product and Product Variant on any of that registration's Registered Product records, or when the selected record only includes a Product and the value matches the Product on any of that registration's Registered Product records. *Not applicable for active substance or manufacturing site registrations. |
|
| Registered Product Characteristic |
Characteristic Type, Characteristic Value, Product*, Product Variant*, Use for UDI |
For product or investigational registrations, Vault adds Registered Product Characteristic records when the selected record has a Product and Product Variant and the values match the Product and Product Variant on any of that registration's Registered Product records, or when the selected record only includes a Product and the value matches the Product on any of that registration's Registered Product records. *Not applicable for active substance or manufacturing site registrations. |
| Registered Packaging Characteristic |
Characteristic Type, Characteristic Value, Packaging, Use for UDI |
For product or investigational registrations, Vault adds Registered Packaging Characteristic records when the Packaging value on the selected record matches the Packaging value on any of that registration's Registered Packaging records. *Not applicable for active substance or manufacturing site registrations. |
| Registered Shelf Life and Storage |
Packaging, Shelf Life, Storage Conditions, Container, Product*, Product Variant* , Inactive ingredient, Active Substance, Use for UDI (device-only) |
For product, investigational, or active substance registrations, Vault adds Registered Shelf Life and Storage records based on the data associated with the Regulatory Objective record. *Not applicable for manufacturing site registrations. |
| Registered Site Role | Manufacturing Site, Site Product Type, Site Role |
*Not applicable for device product, investigational, or active substance registrations. |
| Registered Site Contact | Manufacturing Site, Site Product Type, Site Contact, Site Contact Role |
For manufacturing site registrations, Vault adds Manufacturing Site Contact records when the Manufacturing Site value on the selected record matches the value on the registration. *Not applicable for product, investigational, or active substance registrations. |
| Registered Site Organization | Manufacturing Site, Site Product Type, Organization, Organization Role, Product, Use for UDI |
*Not applicable for investigational or active substance registrations. |
| Registered Authorization | Regulatory Text, Product, Product Variant, Packaging, Use for UDI |
For product and packaging registrations with a Marketed Product, Marketed Product Group, Marketed Product by Site, or Pack Size scope, Vault adds Registered Authorization records when the Product Variant or Product (if Product Variant is blank) on the selected record is a Registered Product of the registration. |
| Registered Regulatory Text | Regulatory Authorization, Product, Product Variant, Packaging, Use for UDI |
For product and packaging registrations with a Marketed Product, Marketed Product Group, Marketed Product by Site, or Pack Size scope, Vault adds Registered Regulatory Text records when: |
Bulk Action Processing Time & Notifications
Bulk creation occurs asynchronously, meaning that there may be a delay before you see the new records, particularly on Vaults with a lot of activity. Once you confirm a bulk creation, Vault puts the action in a queue with other asynchronous tasks. If your Vault’s configuration includes a verification workflow, you’ll receive a notification and CSV when the workflow starts.
When the changes are complete, Vault sends you an email and notification with a link to a CSV file. The CSV link expires after 14 days.
If Vault is unable to complete any of the creation tasks, the CSV file includes an explanation of the errors. Known reasons for these errors include:
- Records that are in an active workflow will not be modified
- Records already in the specified state will not be modified
- Another user is attempting to make the same changes
Related Permissions
Bulk creation requires that your security profile grant Create permission on the objects you’re creating, for example, Registered Product. Vault checks for the required permissions during the asynchronous record creation phase of the process. You may be able to view the action even if it is not available to you. Any field-level security your Admin has configured on these objects may impact record creation as well.
You must also have Read permission on the source records from which you initiate the wizard, for example, Event, Application, or Regulatory Objective, and the records from which the wizard pulls data, for example, Regulatory Objective Product. If the objects use Dynamic Access Control, you must also have at least the Viewer role on the specific records. If your Vault uses field-level security, you must have Read permission on the fields from which Vault pulls data.
|
*In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices:
In existing Vaults, Admins can update these objects manually. |
|
**Vaults created before the 18R3 release may use the Submission object instead of the Regulatory Objective object. |