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, investigational, active substance, and manufacturing site registrations, and registrations for medical devices in these categories.
Note: This feature is only available on RIM Registrations Vaults.
Enabling Regulatory Objective Relationships
Note: In 23R2 (23R1.2), the Create Registrations wizard is enhanced to create planned registrations from Regulatory Objectives, which Vault also references to create registered details. This recommended configuration replaces the legacy configuration, which creates planned registrations from Application records only, and Vault references the Submission’s detail records to create registered details. Both options require Activity and Objective Bundling enablement, and the enhanced configuration requires you to enable an additional Application Setting.
Enabling Activity & 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
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, 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, 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 Matching Custom Fields
Vault can copy 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 copying custom fields for Picklist, Object, Date, DateTime, Yes/No, Text, and Number field types.
In order for Vault to copy matching custom fields, you must configure custom fields with matching names and field types on both objects. You should not configure entry criteria on any matching custom fields on the Registration join objects. If you have object types enabled on any of these objects, configure matching custom fields for all object types.
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 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 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, investigational, active substance, and manufacturing site registrations in bulk, as well as those for medical devices, you must modify your Vault’s configuration according to the sections below.
Note: In 23R2 (23R1.2), the Create Registrations wizard is enhanced to create planned registrations from Regulatory Objectives, which Vault also references to create registered details. This recommended configuration replaces the legacy configuration. Both options require you to review your Vault’s configuration and confirm or update the registration-specific configuration according to the following Enhanced Configuration or Legacy Configuration subsections below. (Depending on when your Vault was created, some configurations may already be in place.) See also Enabling Regulatory Objective Relationships for further details.
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 on the Registration Packaging object’s Product Variant* 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 on the Registration Packaging object’s Product Variant* 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 Regulatory Objective 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
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*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. |