Bulk creation allows you to quickly create Registration records for investigational products based on the data defined in the Application and Submission records for easy and consistent data entry.
Vault creates unique registrations based on the rules that have been configured for each country. This results in registrations with the appropriate level of granularity for each country, depending on whether the registered clinical investigation is related to a drug product or a medical device. Vault can create one registration per investigational product or one registration per study. You can also ensure that registered studies are associated with clinical sites for markets that require registration of each site involved in the investigation.
Note: This feature is only available on RIM Registrations Vaults. Feature visibility relies on the Lead Market (lead_market__rim or lead_market__c) field and the Application: Country relationship.
Values for Investigational Registration Records
When you use bulk registration creation, Vault creates different Registration records based on:
- Values on the related Application record
- Values on that application’s related records
- Values you select during the bulk action
- The Registration Scope for the Registration Type populated during the bulk action
How to Bulk Create Investigational Registrations
Before you start the bulk creation process, you must add all appropriate data to your submission or regulatory objective. When you’re ready to create registrations, Vault includes a wizard to guide you through the process. Labels and options in this wizard may vary depending on your Vault’s configuration.
After you run the Create Registrations wizard, you can’t start the wizard from the same record again until record creation is complete. This prevents Vault from creating duplicate records.
Starting Bulk Creation
Note: In 23R2 (23R1.2), the Create Registrations wizard is enhanced to create planned registrations from a Regulatory Objective based on Application, Regulatory Objective, and other metadata. If your Vault is configured for this enhancement, the Create Registrations action is available from Regulatory Objective records only. If your Vault is configured with the legacy configuration, the action is available from Application records only, and Vault creates planned registrations based on Application, Submission, and other metadata.
To create Registration records for investigational products in bulk:
- Open the associated Application or Regulatory Objective record from the Application or Regulatory Objective tab or from Business Admin.
- Choose Create Registrations from the Actions menu. The action’s availability depends upon your Vault’s configuration (see Note). Additionally, the action is only available if the application has a Lead Market selected or if there are associated Country records through the Application: Country relationship.
- In the Registration Type field, confirm the defaulted value or select one accordingly.
- Select a Submission or Application. The required option depends on your Vault’s configuration (see Note). In either configuration, your selection controls what you see on the Product Details, Packaging Details, and Clinical Study Details steps that you see later in the bulk creation process when selecting details to register.
- If required, select a Regulatory Objective to relate to each created Registration join record. This option is only available if activity and regulatory objective bundling is enabled in your Vault. If available, Vault automatically populates a Regulatory Objective based on the selected Submission.
- Click Next.
- On the Registration Details page, select the Countries for which you want to create registrations. You may remove defaulted countries and add others, but only countries associated with the selected Application or countries selected by default are available here.
- Fill in any additional required Registration fields.
- Click Next to continue in the wizard and select the records to register.
Selecting Details to Register
Note: In 23R2 (23R1.2), the Create Registrations wizard is enhanced to create planned registrations from a Regulatory Objective based on Application, Regulatory Objective, and other metadata. If your Vault is configured for this enhancement, you’ll register Regulatory Objective Product, Regulatory Objective Packaging, and Regulatory Objective Clinical Study records. If your Vault is configured with the legacy configuration, you’ll register Submission Product, Submission Packaging, and Submission Clinical Study records.
After you fill in the registration details, you’ll see the Detail pages in the wizard, where you can select the individual records to register. On each page, you can click on column headers to sort the records or apply filters to object or lifecycle state fields by clicking the filter icon in the column to find records. If your Vault is configured to use object type mapping, you may not need to select object types for the created records.
- On the Product Details page, choose the Submission Product or Regulatory Objective Product records to register. The available records depend on your Vault’s configuration (see Note). Vault selects all records by default, but you can use the checkboxes or Deselect All to make changes.
- Optional: If the submission or regulatory objective (see Note) has both simple and complex products, you can select the checkbox to create separate registrations for all selected products, including simple products that are components of selected complex products.
- If available, select the object type for the Registered Product records, and fill in any other required fields.
- Click Next.
- On the Packaging Details page, choose the Submission Packaging or Regulatory Objective Packaging records to register. The available records depend on your Vault’s configuration (see Note). If available, select the object type for the Registered Packaging records, and fill in any other required fields. If you don’t want to associate any records, you may move to the next step.
- Click Next.
- On the Clinical Study Details page, choose the Submission Clinical Study or Regulatory Objective Clinical Study records to register. The available records depend on your Vault’s configuration (see Note). If available, select the object type for the Registered Clinical Study records, and fill in any other required fields.
- Click Next to proceed to the Confirmation page.
Completing Bulk Creation
On the Confirmation page, review the details of the Registration records you’re creating. Click Finish to start creating records. The records that Vault creates depend on the variables set throughout this process.
About Record Creation
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 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.
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
Registration Naming Patterns
Vault names new Registration records following the naming patterns below:
- Investigational Product
-
{Country > Country Code} – {Product > Product Name}
- Investigational Study or Investigational Site
-
{Country > Country Code} – {Clinical Study > Clinical Study Number}
Copying 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 displays copied custom field values for clinical study details on the Study Details page of the wizard. Vault supports copying custom fields for Picklist, Object, Date, DateTime, Yes/No, Text, and Number field types.
Registration Scope Details
The following are registration scope options and their results:
- Investigational Product
-
Vault creates a Registration record for each combination of Country and Product. 1
- Investigational Study
-
Vault creates a Registration record for each valid combination of Country and Study.
- Investigational Site
-
Vault creates a Registration record for each combination of Country and Study. Vault only creates investigational registrations for studies with a site associated.
If you did not select the Create separate Registrations for any selected Complex Products and their selected component Products checkbox on the Product Details page when selecting details to register, Vault only creates Registration records for the complex products and for any simple products that are not components of the complex products. If you did select this checkbox, Vault creates Registration records for every selected product, including simple products that are components of selected complex products.
Registration Field Auto-Population
When creating Registrations during bulk creation, Vault populates these fields depending on the Registration Scope:
- Name
-
Vault assigns this based on standard, non-editable patterns. If another record exists with the same name, Vault appends a five (5) digit number to the end, for example, “UK – MC2039” and “UK – MC2039-00001”.
- Application
-
A reference relationship is automatically created between new Registrations and the Application from which you started the process.
- Submission
-
This field points to the Submission record selected during bulk creation.
- Country
-
Vault creates Registration records for each selected Country. This field will point to one of the selected Country records.
- Health Authority
-
This field defaults only if there is a single health authority associated with the selected country.
- Product
-
This field points to the Product1 on the Submission Product record selected during bulk creation. Vault only populates this field when the scope is Investigational Product.
- Status
-
This field defaults to the object lifecycle’s starting state.
- Registration Status Date
-
This field defaults to the date when you created the Registration.
- Regulatory Objective
-
This field defaults to the Regulatory Objective you selected in the first step of the creation process or to the Regulatory Objective associated with the Submission you selected.
- Clinical Study Number
-
This field is only populated for Study- or Site-level Countries and will be equal to the Clinical Study selected on the wizard.
Object Relationships
Relationships between Registrations & Product
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Product1 records, as follows:
- Complex Products
-
Vault creates one (1) Registered Product record for each combination of complex Product1, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL. If any product components are listed on the Product Details page of the wizard, Vault creates Registered Product records for each applicable combination of Manufacturer, simple Product1, Product Variant1, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL based on the data on the Submission selected in the wizard.
- Simple Products
-
Vault creates Registered Product records for each combination of Product,1 Product Variant1, Manufacturer, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL on the Submission selected in the wizard.
Relationships between Registrations & Active Substance
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Active Substance records. Vault creates one (1) Registered Active Ingredient record for each combination of Active Substance and Manufacturer related to the Submission selected in the wizard.
Vault does not create Registered Active Substance records if the Active Substance is not related to the Product1 and Product Variant1 on one of the Registered Product records, or if it is not related to the Product1 and Product Variant1 of one of the components of a complex product on one of the Registered Product records. Active substances are related to products and product variants through related Product Variant Active Substance records on the Active Substance record detail page.
Relationships between Registrations & Inactive Ingredient
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Inactive Ingredient records. Vault creates one (1) Registered Inactive Ingredient record for each combination of Inactive Ingredient, Manufacturer, Site Product Type, and Manufacturing Site Role on the Submission selected in the wizard.
Vault does not create Registered Inactive Ingredient records if the Submission Inactive Ingredient is not related to the Product1 and Product Variant1 on one of the Registered Product records, or if it is not related to the Product1 and Product Variant1 of one of the components of a complex product on one of the Registered Product records. Inactive ingredients are related to products and product variants through related Product Variant Inactive Ingredient records on the Inactive Ingredient record detail page.
Relationships between Registrations & Indication
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Indication records.
Vault creates one (1) Registered Indication record for each Indication on the Submission selected in the wizard.
Relationships between Registrations & Packaging
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Packaging records.
Vault creates one (1) Registered Packaging record for each combination of Packaging, Packaging Site, Shelf Life, Product1, Product Variant1, Finished Product Code, Site Product Type, Packaging UDI-DI, and DI Contained Within on the Submission selected in the wizard. Vault does not create Registered Packaging records if the Product1 and Product Variant1 do not match the Product1 and Product Variant1 on one of the Registered Product records. For complex products, the Product Variant field on the Registered Packaging record is expected to be blank.
Relationships between Registrations & Clinical Studies
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Clinical Study records as follows:
- Investigational Product
-
For each Clinical Study associated with the Submission selected in the wizard, Vault creates a new Registered Clinical Study record.
- Investigational Study
-
For each Clinical Study associated with the Submission selected in the wizard, Vault creates a new Registered Clinical Study record when the Clinical Study matches the Clinical Study on the Registration record.
- Investigational Site
-
For each Clinical Study associated with the Submission selected in the wizard, Vault creates a new Registered Clinical Study record when the Clinical Study matches the Clinical Study on the Registration record and has a Site.
Relationships between Registrations & Product Classifications
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Product Classification records.
Vault creates one (1) Registered Product Classification record for each combination of Product1, Product Variant1, and Classification on the Submission selected in the wizard. Vault does not create Registered Product Classification records if a Product Variant1 was specified and the Product1 and Product Variant1 do not match the Product1 and Product Variant1 on one of the Registered Product records. Vault also does not create Registered Product Classification records if a Product Variant1 was not specified and the Product1 does not match the Product1 on one of the Registered Product records.
Relationships between Registrations & Product Characteristics
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Product Characteristics records.
Vault creates one (1) Registered Product Characteristic record for each combination of Product1, Product Variant1, Characteristic Type, and Characteristic Value on the Submission selected in the wizard. Vault does not create Registered Product Characteristic records if a Product Variant1 was specified and the Product1 and Product Variant1 do not match the Product1 and Product Variant1 on one of the Registered Product records. Vault also does not create Registered Product Characteristic records if a Product Variant1 was not specified and the Product1 does not match the Product1 on one of the Registered Product records.
Relationships between Registrations & Packaging Characteristics
When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Packaging Characteristics records.
Vault creates one (1) Registered Packaging Characteristic record for each combination of Packaging, Characteristic Type, and Characteristic Value on the Submission selected in the wizard. Vault does not create Registered Packaging Characteristic records if the Packaging does not match the Packaging on one of the Registered Packaging records.
Relationships between Registrations & Shelf Life
When creating Registration records, Vault also creates many-to-many relationships between the Registration and Shelf Life records.
Vault creates one (1) Registered Shelf Life and Storage record for each combination of Packaging, Shelf Life, Storage Conditions, Container, Product, Product Variant, Inactive ingredient, and Active Substance on the Submission selected in the wizard.
Relationships between Registrations & Regulatory Objectives
If activity and regulatory objective bundling is enabled in your Vault, Vault also creates many-to-many relationships between the created Registrations and the Regulatory Objective record you selected in the wizard. Vault creates a Registration Regulatory Objective join record for each registration created.
If activity and regulatory objective bundling is not enabled in your Vault but the Submission record you selected in the wizard has a related regulatory objective, Vault also creates many-to-many relationships between the created Registration records and the submission’s related regulatory objective. Vault creates a Registration Regulatory Objective join record for each registration created.
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. When the changes are complete, a note appears in your Notifications page and Vault sends you an email with a link to download the CSV summary file.
If Vault is unable to complete any of the creation tasks, the CSV file will include 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
- No Registration Scope records match the selected Country and Registration Type
Related Permissions
Bulk creation requires that your security profile grant Create permission on the objects you’re creating, for example, Registration and Registered Indication. Note that 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. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13 ↩14 ↩15 ↩16 ↩17 ↩18 ↩19 ↩20 ↩21 ↩22 ↩23 ↩24 ↩25 ↩26 ↩27 ↩28 ↩29 ↩30 ↩31 ↩32 ↩33 ↩34 ↩35 ↩36 ↩37 ↩38 ↩39 ↩40 ↩41 ↩42