# Managing Registered Details (RIM) 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.
## 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 {#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][15]. 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: 1. Navigate to the _Regulatory Objective_ record. 2. From the **Actions** menu, select **Manage Registered Details**. We recommend only updating registrations of the same object type, for example, _Investigational Registrations_. 3. 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. 4. 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. 5. If your Vault is configured to use the [registration verification workflow][6], review the workflow details. Depending on your Vault's configuration, you may need to select the users or groups that will receive review tasks. 6. 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. 7. Click **Next**. 8. 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][2]** page, the **[Registered Details][2]** pages, or the **[Add New Details][3]** page. ### Working with Registration Details & Registered Details {#reg-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, as well as _Text_ fields of 128 characters or less. 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.
### Adding New Details {#add-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: 1. Expand a country to see its _Registration_ records. 2. 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, as well as _Text_ fields of 128 characters or less. Filtering is not supported for other field types. 3. 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. 4. Click **Add New Details**. 5. 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][10] to new registered details records if there is a matching field defined in the relevant _Registered Detail_ Object. 6. If necessary, select the object type for each of the _Registered Detail Types_. 7. Select a **Lifecycle State** for each of the _Registered Detail Types_. 8. Fill in any required fields. 9. Click **OK**. When you close the dialog, Vault displays an icon (i 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][4] and [updating existing details][5] below. ### Registration Verification {#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) {#existing-detail-fields} 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) {#new-detail-fields} #### Copying Custom Fields {#copy-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)
  • For registrations with a Marketed Pack Size or Marketed Product Variant scope, Vault adds Registered Product records when the Product and Product Variant match what the values on the registration, or when they match one of the components of a complex product on the registration.
  • For registrations with a Marketed Product by Site scope, Vault adds Registered Product records when the Product and Manufacturing Site match the values on the registration, or when they match one of the components of a complex product on the registration.
  • For registrations with a Marketed Product scope, Vault adds Registered Product records when the Product matches the value on the registration, or when the Product and Product Variant match one of the components of a complex product on the registration.
  • For registrations with a Marketed Product Group, Investigational Product, Investigational Study, or Investigational Site scope, Vault adds Registered Product records for all product details selected in the wizard.
  • For registrations with an Active Substance scope, Vault adds Registered Product records for all product details selected in the wizard when the Product Variant is associated with the Active Substance on the registration, when the Product is a complex product and at least one of its components has an association with the Active Substance on the registration, or when the Product is a simple product and the Product Variant is not specified.

*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)
  • For product or investigational registrations, Vault adds Registered Active Substance records when the Active Substance is associated with the Product and Product Variant on any of that registration's Registered Product records, or if the Active Substance is associated with one or more of the components of any complex products on that registration's Registered Product records.
  • For active substance registrations, Vault adds Registered Active Substance records when the Active Substance matches the value on the registration.

*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)
  • For registrations with a Marketed Pack Size scope, Vault adds Registered Packaging records when the Product, Product Variant, and Packaging match the values on the registration.
  • For registrations with a Marketed Product Variant scope, Vault adds Registered Packaging records when the Product and Product Variant match the values on the registration. For complex products, the Product Variant field on the Registered Packaging record is expected to be blank.
  • For registrations with a Marketed Product by Site scope, Vault adds Registered Packaging records when the Product, Product Variant, and Finished Product Manufacturer match the values on any of that registration's Registered Product records.
  • For registrations with a Marketed Product, Marketed Product Group, Investigational Product, Investigational Study, Investigational Site, or Active Substance scope, Vault adds Registered Packaging records when the Product and Product Variant match the values on any of that registration's Registered Product records.

*Not applicable for manufacturing site registrations.

Registered Clinical Study

Clinical Study, Country, Site, Use for UDI (device-only)

  • For registrations with an Investigational Product scope, Vault adds Registered Clinical Study records for all records you selected in the wizard.
  • For registrations with an Investigational Study scope, Vault adds Registered Clinical Study records when the Clinical Study on the selected record matches the Clinical Study on the registration.
  • For registrations with an Investigational Site scope, Vault adds Registered Clinical Study records when the Clinical Study on the selected record matches the Clinical Study on the registration and has a Site.
  • For registrations with a Marketed Product, Marketed Product Group, Marketed Product by Site, or Pack Size scope, Vault adds Registered Clinical Study records when the Clinical Study on the selected record matches the value on the registration.

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

Classification, Product*, Product Variant*, Use for UDI

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
  • For manufacturing site registrations, Vault adds Manufacturing Site Role records when the Manufacturing Site value on the selected record matches the value on the registration.
  • For marketed drug product registrations, Vault adds Manufacturing Site Role records based on the data associated with the Regulatory Objective record.

*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
  • For manufacturing site registrations, Vault adds Manufacturing Site Organization records when the Manufacturing Site value on the selected record matches the value on the registration.
  • For product and packaging registrations with a Marketed Product, Marketed Product Group, Marketed Product by Site, or Pack Size scope, Vault adds Registered Site Organization records when the Product value on the selected record matches the value on the registration.

*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:

  • The Packaging value on the selected record matches the Packaging value on a Registered Packaging record of the registration.
  • The Product Variant (if Packaging is blank) orProduct (if Packaging and Product Variant are blank) on the selected record is a Registered Product of the registration.
## 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 {#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:

  • The Product (product__v) object is now Product Family.
  • The Drug Product (drug_product__v) object is now Product.
  • The Product Detail (product_detail__v) object is now Product Variant.

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.

[2]: #reg-details [3]: #add-new-details [4]: #new-detail-fields [5]: #existing-detail-fields [6]: #verification [10]: #copy-custom-fields [14]: /wordpress/39108 [15]: #permissions [comment]: # Screenshot removed (Action UI impact) from end of section "Working with Registration Details & Registered Details". file="MRD_Update_Details_20r22.png" [comment]: # Screenshot removed (Action UI impact) from end of section "Adding New Details" file="MRD_Add_New_Details_20r22.png"