# Bulk Creating Investigational Registrations (RIM) 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.
## 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
To create _Registration_ records for investigational products in bulk: 1. Open the associated _Application_ or _Regulatory Objective_ record from the **Application** or **Regulatory Objective** tab or from **Business Admin**. 2. 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. 3. In the **Registration Type** field, confirm the defaulted value or select one accordingly. 4. 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][1]. 5. 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_. 6. Click **Next**. 7. 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. 8. Fill in any additional required _Registration_ fields. 9. Click **Next** to continue in the wizard and select the records to register. ### Selecting Details to Register {#selecting-details}
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. 1. 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. 2. 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. 3. If available, select the object type for the _Registered Product_ records, and fill in any other required fields. 4. Click **Next**. 5. 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. 6. Click **Next**. 7. 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. 8. 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 {#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 {#naming-patterns} When system-managed naming is enabled for the _Registration_ object, Vault follows the configured naming pattern. Otherwise, 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][1], 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 : When system-managed naming is enabled for the _Registration_ object, Vault follows the configured naming pattern. Otherwise, Vault assigns this based on standard, [non-editable patterns][2]. If another record exists with the same name, Vault appends a five-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 _Product_[^1] 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 _Product_[^1] records, as follows: Complex Products : Vault creates one (1) _Registered Product_ record for each combination of complex _Product_[^1], _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 _Product_[^1], _Product Variant_[^1], _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 Variant_[^1], _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 _Product[^1]_ and _Product Variant[^1]_ on one of the _Registered Product_ records, or if it is not related to the _Product[^1]_ and _Product Variant[^1]_ 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 _Product[^1]_ and _Product Variant[^1]_ on one of the _Registered Product_ records, or if it is not related to the _Product[^1]_ and _Product Variant[^1]_ 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_, _Product[^1]_, _Product Variant[^1]_, _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 _Product[^1]_ and _Product Variant[^1]_ do not match the _Product[^1]_ and _Product Variant[^1]_ 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 _Product[^1]_, _Product Variant[^1]_, and _Classification_ on the _Submission_ selected in the wizard. Vault does not create _Registered Product Classification_ records if a _Product Variant[^1]_ was specified and the _Product[^1]_ and _Product Variant[^1]_ do not match the _Product[^1]_ and _Product Variant[^1]_ on one of the _Registered Product_ records. Vault also does not create _Registered Product Classification_ records if a _Product Variant[^1]_ was not specified and the _Product[^1]_ does not match the _Product[^1]_ 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 _Product[^1]_, _Product Variant[^1]_, _Characteristic Type_, and _Characteristic Value_ on the _Submission_ selected in the wizard. Vault does not create _Registered Product Characteristic_ records if a _Product Variant[^1]_ was specified and the _Product[^1]_ and _Product Variant[^1]_ do not match the _Product[^1]_ and _Product Variant[^1]_ on one of the _Registered Product_ records. Vault also does not create _Registered Product Characteristic_ records if a _Product Variant[^1]_ was not specified and the _Product[^1]_ does not match the _Product[^1]_ 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_action} 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. [^1]: 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. [1]: #selecting-details [2]: #naming-patterns