# Configuration for Bulk Creating Registrations (RIM) Vault provides a wizard that enables users to create product, investigational, active substance, and manufacturing site _Registrations_ in bulk. Bulk creation allows users to quickly create _Registration_ records based on the data defined in the _Application_ and _Submission_ records for easy and consistent data entry. Although this feature is automatically enabled on RIM Registrations Vaults, users can't use it until you perform some configuration. See details below about configuration needed to bulk create [product](/en/lr/43102/), [investigational](/en/lr/45395/), [active substance](/en/lr/65511/), and [manufacturing site](/en/lr/65523/) registrations, and registrations for medical devices in these categories.
## Enabling Regulatory Objective Relationships {#enabling-regulatory-objective-relationships}
### Enabling Activity & Objective Bundling {#enabling-activity-and-objective-bundling} In order for Vault to automatically associate new _Registration_ records created in bulk with _Regulatory Objectives_, you must enable activity and regulatory objective bundling in your Vault. Navigate to **Admin > Settings > Application Settings** and select the **Enable Activity and Objective Bundling** checkbox. When configured alone, this setting allows users to create registrations based on _Application_, _Submission_, and other metadata, and the related action is only available from _Application_ records. ### Enabling Regulatory Objective Data as Source {#enabling-regulatory-objective-data-as-source} When Activity and Objective Bundling is configured with the **Use regulatory objective data as source when bulk creating registrations** setting, users can create registrations based on _Application_, _Regulatory Objective_, and other metadata. When enabled, the related action is only available from _Regulatory Objective_ records. We recommend this enhanced configuration, especially for scenarios where a submission is not required to market a product (for example, for low-risk medical devices). This configuration also creates a more consistent user experience, as users can both create and manage a registration from a _Regulatory Objective_. ## About Registration Scopes In past releases, Vault used the _Registration Scope_ and _Clinical Trial Authorization Scope_ fields on the _Country_ object to define registration scopes for a country. As of the 19R3 release, Vault uses a separate _Registration Scope_ object. Your Vault must contain a _Registration Scope_ record for each _Registration_ object type for each active _Country_ record in your Vault in order for the wizard to work. The _Registration Scope_ object is a child of the _Country_ object. The object contains a picklist-type field, also called _Registration Scope Type_, with the following values: * _Marketed Product Variant_ * _Marketed Pack Size_ * _Marketed Product_ * _Marketed Product by Site_ * _Marketed Product Group_ * _Investigational Product_ * _Investigational Study_ * _Investigational Site_ * _Active Substance_ * _Manufacturing Site_ ### Configuring Registration Scopes In order for the bulk creation wizard to work, your Vault must contain one (1) _Registration Scope_ record for all combinations of active _Country_ records and active _Registration_ object types in your Vault. Whenever you create a new _Country_ record or _Registration_ object type, or when one of these changes from inactive to active, you must add new _Registration Scope_ records for the new combinations of the active _Countries_ and active _Registration_ object types. ### Example: Argentina If the _Country_ record for Argentina in your Vault changed from inactive to active, you'd need to create the following _Registration Scope_ records: |Country|Object Type Name|Registration Scope Picklist Option| |--- |--- |--- | |Argentina|marketed_drug_product_registration__v|Marketed Product Variant| |Argentina|marketed_device_product_registration__v|Marketed Product Group| |Argentina|custom_registration_type__c|Marketed Pack Size| |Argentina|investigational_registration__v|Investigational Site| |Argentina|investigational_device_registration__v|Investigational Study| |Argentina|active_substance__v|Active Substance| |Argentina|manufacturing_site__v|Manufacturing Site| ## Configuring Object Access If your Vault is configured to use only the [_Activity and Objective Bundling_ setting][6], update the _Submission_ and _Registration_ object page layouts with related object sections for each supported join object. This ensures users can create _Submission_ join records and that Vault can carry relationships over to _Registration_ join records. If your configuration is enhanced with the [_Use regulatory objective data as source when bulk creating registrations_ setting][7], update the _Regulatory Objective_ and _Registration_ object page layouts with related object sections for each supported join object. This ensures users can create _Regulatory Objective_ join records and that Vault can carry relationships over to _Registration_ join records. ## Configuring Fields ### Configuring Custom Fields {#configuring_to_copy_matching_custom_fields} Vault can copy or default custom field values from _Submission_ join records to the new _Registration_ join records as long as custom fields with matching names and field types are configured on both objects. Vault supports this functionality for _Picklist_, _Object_, _Date_, _DateTime_, _Yes/No_, _Text_, and _Number_ field types. The method you use to configure this functionality depends on whether the configuration should copy a value from a field on the source record, or default a value from a formula on the target record. These differences are summarized in the table below. | Goal | Field Name | Source Field Permission | Target Field Permission | |---|---|---|---| | Copy | Source and target object field names must be the same, for example `field_name__c` and `field_name__c`. | Read | Edit | | Default | Source and target object field names must be different, for example `ro_autoname_calc__c` and `sub_autoname_calc__c`. | None | None | Additionally, this functionality requires that: * The fields you configure are also configured for any object types. * Selected _Registration_ join object fields are not configured within lifecycle state entry criteria. ### About the _Use for Registrations_ Field {#about-the-use-for-registrations-field} The _Use for Registrations_ Yes/No field allows your organization to specify which records Vault considers when creating [registrations](/en/lr/43102/) in bulk. 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. To do this, add the _Use for Registrations_ field to the object page layouts of 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_ ### Configuring Fields for Indications & Orphan Designation Vault uses the _Full Indication Text_ object and its related objects to track the full text required for therapeutic indications, as documented in section 4.1 of the Summary of Product Characteristics (SmPC). Additionally, Vault uses the _Regulatory Authorisation_ object to store data related to special authorisations, such as Orphan Designation or Advanced Therapy Medicinal Products (ATMPs). If your organization requires this IDMP reporting data to be populated during bulk creation, add the _Full Indication Text_ and _Orphan Designation_ fields to the object page layouts of the following objects: * _Application Indication_ * _Event Indication_ * _Regulatory Objective Indication_ * _Submission Indication_ ## Configuring Object Type Mapping The _Object Type Mapping_ object supports customers who want to create registrations in bulk for both drug products and medical device products. This object allows you to configure which object types to use for particular registered details, such as _Registered Product_ records, depending on the _Registration Type_ the user selects in the bulk creation wizard. Object type mapping ensures that the correct drug-related submission details will be carried over to the corresponding registered details when users bulk create registrations for drug products or active substances, and that the correct device-related submission details will be carried over to the corresponding registered details when users bulk create registrations for medical device products. See [Configuring Object Type Mapping](/en/lr/62601/) for more information and a typical set of mappings for the drug and medical device object types. ## Registration-Specific Configuration To enable users to create [product](/en/lr/43102/), [investigational](/en/lr/45395/), [active substance](/en/lr/65511/), and [manufacturing site](/en/lr/65523/) registrations in bulk, as well as those for medical devices, you must modify your Vault's configuration according to the sections below.
### Configuration for Bulk Creating Product Registrations #### Enhanced Configuration To enable users to create product registrations in bulk, you must modify the _Regulatory Objective_ object page layout to add a section for _Related Object: Regulatory Objective Packaging_. We also recommend that you update the _Registrations_ object page layout: * Add a section for _Related Object: Registered Product_ * Remove the _Related Object: Registered Product Variant_ section #### Legacy Configuration To enable users to create product registrations in bulk, you must modify the _Submission_ object page layout to add a section for _Related Object: Submission Packaging_. We also recommend that you update the _Registrations_ object page layout: * Add a section for _Related Object: Registered Product_ * Remove the _Related Object: Registered Product Variant_ section ### Configuration for Bulk Creating Investigational Registrations #### Enhanced Configuration To enable users to create investigational registrations in bulk, you must add a section for _Related Object: Regulatory Objective Packaging_ on the _Regulatory Objective_. We also recommend that you perform the following configuration tasks: * Depending on when your Vault was created, you may need to remove any [reference constraints](/en/lr/75340/) on the _Registration Packaging_ object's _Product Variant[\*][4]_ field. Vault populates fields on the _Registration_, and if a reference constraint exists that compares to the _Registration_ record, Vault will not create the _Registration Packaging_ records for the investigational registration. * Add a section to the _Registrations_ object page layout for _Related Object: Registered Clinical Studies._ #### Legacy Configuration To enable users to create investigational registrations in bulk, you must add a section for _Related Object: Submission Packaging_ on the _Investigational Submission Detail Page Layout_. We also recommend that you perform the following configuration tasks: * Depending on when your Vault was created, you may need to remove any [reference constraints](/en/lr/75340/) on the _Registration Packaging_ object's _Product Variant[\*][4]_ field. Vault populates fields on the _Registration_, and if a reference constraint exists that compares to the _Registration_ record, Vault will not create the _Registration Packaging_ records for the investigational registration. * Add a section to the _Registrations_ object page layout for _Related Object: Registered Clinical Studies._ ### Configuration for Bulk Creating Medical Device Registrations #### Enhanced Configuration To enable users to create registrations for medical devices in bulk, you must modify the _Regulatory Objective_ object page layout: * Add a section for _Related Object: Regulatory Objective Product Classification_ * Add a section for _Related Object: Regulatory Objective Product Characteristic_ * Add a section for _Related Object: Regulatory Objective Packaging Characteristic_ #### Legacy Configuration To enable users to create registrations for medical devices in bulk, you must modify the _Submission_ object page layout: * Add a section for _Related Object: Submission Product Classification_ * Add a section for _Related Object: Submission Product Characteristic_ * Add a section for _Related Object: Submission Packaging Characteristic_ ### Configuration for Bulk Creating Active Substance Registrations #### Enhanced Configuration To enable users to create active substance registrations in bulk, you must: * Ensure the _Active Substance Registration_ object type is active on the _Registration_ object. * Update the _Active Substance Registration_ object type page layout to add a _Related Object_ section for _Registered Active Substance_ #### Legacy Configuration To enable users to create active substance registrations in bulk, you must: * Ensure the _Active Substance Registration_ object type is active on the _Registration_ object. * Update the _Active Substance Registration_ object type page layout to add a _Related Object_ section for _Submission Active Substance_ ### Configuration for Bulk Creating Manufacturing Site Registrations #### Enhanced Configuration To enable users to create manufacturing site registrations in bulk, you must update the following object page layouts: * Update the _Regulatory Objective_ object page layout to add _Related Object_ sections for the _Regulatory Objective Site Role_, _Regulatory Objective Site Contact_, and _Regulatory Objective Organization_ objects. * Update the _Manufacturing Site Registration_ page layout to add _Related Object_ sections for the _Registered Site Role_, _Registered Site Contact_, and _Registered Organization_ objects. In addition, you must: * Ensure the _Manufacturing Site Registration_ object type is active on the _Registration_ object. * Create object lifecycles for the _Registered Site Role_, _Registered Contact_, and _Registered Organization_ objects. * Create _Controlled Vocabulary_ records for application types, submission types, and submission subtypes for _Manufacturing Site_ application and submissions. You must also create corresponding _Constraint_ records for _Application_ and _Submission_ so that Vault can display the appropriate application types, submission types, and submission subtypes depending on the application's region or country. * Create _Controlled Vocabulary_ records for _Manufacturing Site Roles_, _Manufacturing Site Contact Roles_, and _Manufacturing Site Organization Roles_. You must also create corresponding _Constraint_ records for _Manufacturing Site Role_, and _Manufacturing Site Contact Role_ to control which roles are available for which product types, such as drug products or medical devices. #### Legacy Configuration To enable users to create manufacturing site registrations in bulk, you must update the following object page layouts: * Update the _Submission_ object page layout to add _Related Object_ sections for the _Submission Site Role_, _Submission Site Contact_, and _Submission Organization_ objects. * Update the _Regulatory Objective_ object page layout to add _Related Object_ sections for the _Regulatory Objective Site Role_, _Regulatory Objective Site Contact_, and _Regulatory Objective Organization_ objects. * Update the _Manufacturing Site Registration_ page layout to add _Related Object_ sections for the _Registered Site Role_, _Registered Site Contact_, and _Registered Organization_ objects. In addition, you must: * Ensure the _Manufacturing Site Registration_ object type is active on the _Registration_ object. * Create object lifecycles for the _Registered Site Role_, _Registered Contact_, and _Registered Organization_ objects. * Create _Controlled Vocabulary_ records for application types, submission types, and submission subtypes for _Manufacturing Site_ application and submissions. You must also create corresponding _Constraint_ records for _Application_ and _Submission_ so that Vault can display the appropriate application types, submission types, and submission subtypes depending on the application's region or country. * Create _Controlled Vocabulary_ records for _Manufacturing Site Roles_, _Manufacturing Site Contact Roles_, and _Manufacturing Site Organization Roles_. You must also create corresponding _Constraint_ records for _Manufacturing Site Role_, and _Manufacturing Site Contact Role_ to control which roles are available for which product types, such as drug products or medical devices. ## Configuring User Permissions In order for users to create registrations in bulk, you must ensure that their security profiles are configured correctly. Users need: * _Create_ permission on the objects they're creating, for example, _Registration_, _Registered Product_, _Registered Packaging_, and more * _Read_ permission on the source records from which they initiate the wizard, for example, _Event_, _Application_, or _Regulatory Objective_, and the records from which the wizard pulls data, for example, _Regulatory Objective Product, Regulatory Objective Packaging_, and more * If the objects use Dynamic Access Control, users need at least the _Viewer_ role on the specific records * If your Vault uses field-level security, users 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.](/en/lr/15057/#customizestandardobjects)

[4]: #footnote [5]: #enabling-regulatory-objective-relationships [6]: #enabling-activity-and-objective-bundling [7]: #enabling-regulatory-objective-data-as-source