Vault provides a wizard that allows users to update registration data or to add or update related registered details records after they receive notification from a Health Authority that their Regulatory Objective is approved. Within the Manage Registered Details wizard, users can perform targeted data updates, either individually or in bulk, so changes impact only the intended registration records.
Although this feature is automatically enabled on RIM Registrations Vaults, users can’t use it until you perform some configuration. This article discusses the configuration needed to use the Manage Registered Details wizard.
Note: This feature is only available on RIM Registrations Vaults.
Settings
All Vaults created after the 18R3 release have the Use regulatory objective data as source in manage registered details wizard setting enabled on the Admin > Settings > Application Settings page. This setting allows Vault to pull data from Regulatory Objective records rather than Submission records to create registration data. If this setting isn’t already enabled in your Vault, we recommend enabling it and updating your business processes to use regulatory objectives, if possible.
Note: Your Vault must use the Regulatory Objective object as the source of data in the Manage Registered Details wizard in order to support object type mapping, medical device registered details objects, and the registration verification workflow.
Configuration Overview
Complete the following steps to fully configure this feature:
- Ensure that your Vault has an active object lifecycle for the Registration object, the Regulatory Objective object, and each registered detail object, for example, Registered Product, Registered Packaging, and Registered Product Characteristic. If any of these objects doesn’t have a lifecycle already, you must create one.
- Configure the Manage Registered Details user action on at least one state in your Vault’s Regulatory Objective lifecycle.
- If not already defined, update the Regulatory Objective* object page layout to add a section for Related Object: Regulatory Objective Packaging.
- Update the Registrations object page layout to add a section for Related Object: Registered Product and to remove the Related Object: Registered Product Variant section.
- Enable the Enable inline editing for object list pages setting in Admin > Settings > General Settings under User Interface Options.
- Optional: Add the Use for Registrations Yes/No field to the object page layouts of select relationship detail records. With this configuration, users can select No to exclude a record from consideration when the wizard creates the Registration and other registered details.
- Optional: Configure fields to support Indications and Orphan Designations.
After you complete the step above, we recommend reviewing constraints on the Registered Shelf Life and Storage object to prevent record creation failures. Navigate to the Shelf Life field on the Device object type and verify that the Criteria VQL field refers to the correct name for the Shelf Life object’s Packaged Device Product object type. Unless you have relabeled the object type name, the Criteria VQL field should be set to: object_type__vr.name__v = 'Packaged Device Product' AND ( id IN (SELECT id FROM product_shelf_life_and_storage__vr WHERE product__v = {{this.product__v}}) ).
Configuring Object Fields
Restricted Object Fields
By default, users cannot update the fields below in the Manage Registered Details wizard. You can change a field’s updatability via configuration. You should not define entry criteria that use these fields.
| Object | Fields |
|---|---|
| Registration | Active Substance Application Clinical Study (if populated) Country Manufacturing Site Product Product Variant (if populated) Regulatory Objective Site Product Type |
| Registered Active Substance | Active Substance Application Manufacturer Manufacturing Site Role Registration Regulatory Objective (will be populated by the wizard) Site Product Type |
| Registered Product | Application Manufacturer Manufacturing Site Role Product Product Information URL Product Variant Registration Regulatory Objective (will be populated by the wizard) Risk Class Site Product Type |
| Registered Packaging | Application DI Contained Within Finished Product Finished Product Code Finished Product Manufacturer Finished Product Variant Manufacturing Site Packaging Packaging Site Packaging UDI-DI Registration Regulatory Objective (will be populated by the wizard) Shelf Life Site Product Type |
| Registered Inactive Ingredient | Application Inactive Ingredient Manufacturer Manufacturing Site Role Registration Regulatory Objective (will be populated by the wizard) Site Product Type |
| Registered Clinical Study | Application Registration Regulatory Objective (will be populated by the wizard) Site Study |
| Registered Indication | Application Full Text Translation IDMP Full Indication Text Indication Orphan Designation Registration Regulatory Objective (will be populated by the wizard) |
| Registered Product Classification | Classification Product Product Variant Registration Regulatory Objective (will be populated by the wizard) |
| Registered Product Characteristic | Characteristic Type Characteristic Value Product Product Variant Registration Regulatory Objective (will be populated by the wizard) |
| Registered Packaging Characteristic | Characteristic Type Characteristic Value Packaging Registration Regulatory Objective (will be populated by the wizard) |
| Registered Packaged Medicinal Product | Packaging Registration Regulatory Objective |
| Registered Shelf Life and Storage | Active Substance Container Inactive Ingredient Packaging Product Product Variant Shelf Life Storage Conditions |
| Registered Site Role | Manufacturing Site Registration Regulatory Objective (will be populated by the wizard) Site Product Type Site Role |
| Registered Site Contact | Contact Contact Role Manufacturing Site Registration Regulatory Objective (will be populated by the wizard) Site Product Type |
| Registered Site Organization | Manufacturing Site Organization Organization Role Registration Regulatory Objective (will be populated by the wizard) Site Product Type |
| Registered Regulatory Text | Packaging Product Product Variant Regulatory Text |
| Registered Authorization | Product Product Variant Regulatory Authorization |
Configuring Matching Custom Fields
When users select Add New Details, Vault can copy custom field values from the Regulatory Objective or Submission record to the corresponding registered details records. Vault supports copying matching custom fields for the following field types: Picklist, Object, Date, DateTime, Yes/No, Text, and Number. Vault does not support copying matching custom fields for the Document field type.
You should not configure entry criteria that use matching custom fields on the registered details objects. If you have object types enabled on any of these objects, configure matching custom fields on all object types. These fields should not be mandatory on any object types.
Vault copies custom field values from the Regulatory Objective record when the Use regulatory objective data as source in manage registered details wizard setting is enabled. When this setting is not enabled, Vault copies custom field values from the Submission record.
About the Use for Registrations Field
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.
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 available when managing registered details, 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
About Object Type Mapping
Vault uses object type mapping to determine which object types to use, depending on the object types of the Registration records selected in the wizard. This is especially important for registrations with a combination of drug product, medical device product, and packaging details.
To do this, the wizard checks for active Object Type Mapping records you’ve created and, based on that mapping data, selects the object types. If there are no active records, the wizard automatically selects the target object type by comparing the Names of the source and target object types (for example, device_intended_use__v). If the Name values do not match, Vault prompts the user to select the target object type.
About the Object Type Mapping Object
The Object Type Mapping object supports customers who want to manually manage registered details for both drug products and medical device products. See Configuring Object Type Mapping for Registrations for more information and a sample set of mappings.
Configuring Registration Verification
You can configure a verification workflow as part of the Managed Registered Details process. When this feature is enabled, users must complete workflow tasks to verify updates to registrations and registered details before Vault commits the changes to the impacted records. See Configuring Registration Verification for more information.
|
*Vaults created before the 18R3 release may use the Submission object instead of the Regulatory Objective object. |