# Configuring Manage Registered Details (RIM)

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 <a href="/en/gr/43108/">Manage Registered Details wizard</a>, 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.

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      <p><strong>Note</strong>: This feature is only available on RIM Registrations Vaults.</p>
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## Settings {#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.

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      <p><strong>Note</strong>: Your Vault must use the <em>Regulatory Objective</em> 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.</p>
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## Configuration Overview

Complete the following steps to fully configure this feature:

  1. 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 <a href="/en/gr/30683/">create one</a>.
  2. Configure the **Manage Registered Details** <a href="/en/gr/59885/#user-actions">user action</a> on at least one state in your Vault's _Regulatory Objective_ lifecycle.
  3. If not already defined, update the _Regulatory Objective[\*][5]_ object page layout to add a section for _Related Object: Regulatory Objective Packaging_.
  4. 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.
  5. Enable the _Enable inline editing for object list pages_ setting in **Admin > Settings > General Settings** under **User Interface Options**.
  6. Optional: Add the [_Use for Registrations_][9] 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.
  7. Optional: Configure fields to support [Indications and Orphan Designations][10].

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 {#restricted-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 <a href="/en/gr/59885/#entry_criteria">entry criteria</a> that use these fields.

|Object|Fields|
|--- |--- |
|Registration|Active Substance<br>Application<br>Clinical Study (if populated)<br>Country<br>Manufacturing Site<br>Product<br>Product Variant (if populated)<br>Regulatory Objective<br> Site Product Type|
|Registered Active Substance|Active Substance<br>Application<br>Manufacturer<br>Manufacturing Site Role<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site Product Type|
|Registered Product|Application<br>Manufacturer<br>Manufacturing Site Role<br>Product<br>Product Information URL<br>Product Variant<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Risk Class<br>Site Product Type|
|Registered Packaging|Application<br>DI Contained Within<br>Finished Product<br>Finished Product Code<br>Finished Product Manufacturer<br>Finished Product Variant<br>Manufacturing Site<br>Packaging<br>Packaging Site<br>Packaging UDI-DI<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Shelf Life<br>Site Product Type|
|Registered Inactive Ingredient|Application<br>Inactive Ingredient<br>Manufacturer<br>Manufacturing Site Role<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site Product Type|
|Registered Clinical Study|Application<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site<br>Study|
|Registered Indication|Application<br>Full Text Translation<br>IDMP Full Indication Text<br>Indication<br>Orphan Designation<br>Registration<br>Regulatory Objective (will be populated by the wizard)|
|Registered Product Classification|Classification<br>Product<br>Product Variant<br>Registration<br>Regulatory Objective (will be populated by the wizard)|
|Registered Product Characteristic|Characteristic Type<br>Characteristic Value<br>Product<br>Product Variant<br>Registration<br>Regulatory Objective (will be populated by the wizard)|
|Registered Packaging Characteristic|Characteristic Type<br>Characteristic Value<br>Packaging<br>Registration<br>Regulatory Objective (will be populated by the wizard)|
|Registered Packaged Medicinal Product|Packaging<br>Registration<br>Regulatory Objective|
|Registered Shelf Life and Storage|Active Substance<br>Container<br>Inactive Ingredient<br>Packaging<br>Product<br>Product Variant<br>Shelf Life<br>Storage Conditions|
|Registered Site Role|Manufacturing Site<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site Product Type<br>Site Role|
|Registered Site Contact|Contact<br>Contact Role<br>Manufacturing Site<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site Product Type|
|Registered Site Organization|Manufacturing Site<br>Organization<br>Organization Role<br>Registration<br>Regulatory Objective (will be populated by the wizard)<br>Site Product Type|
|Registered Regulatory Text|Packaging<br>Product<br>Product Variant<br>Regulatory Text|
|Registered Authorization|Product<br>Product Variant<br>Regulatory Authorization|


### Configuring Custom Fields

When users select **Add New Details**, Vault can copy or default custom field values from the _Regulatory Objective_ or _Submission_ record to the corresponding registered details records. Vault supports this functionality 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.

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, however the object type field cannot be configured with the _User must always enter a value (required)_ option.
  * Selected registered details object fields are not configured within lifecycle state entry criteria.



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      <p><strong>Note</strong>: Vault copies or defaults custom field values from the <em>Regulatory Objective</em> record when the <em>Use regulatory objective data as source in manage registered details wizard</em> <a href="/en/gr/60452/#settings">setting</a> is enabled. When this setting is not enabled, Vault copies custom field values from the <em>Submission</em> record.</p>
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### 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 <a href="/en/gr/43108/">registered details</a>.

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 {#configuring-fields-for-indications-and-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 {#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 <a href="/en/gr/62601/">Configuring Object Type Mapping for Registrations</a> for more information and a sample set of mappings.

## Configuring Registration Verification {#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 <a href="/en/gr/71639/">Configuring Registration Verification</a> for more information.

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        <a id="footnote"></a>*Vaults created before the 18R3 release may use the <em>Submission</em> object instead of the <em>Regulatory Objective</em> object.
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 [5]: #footnote
 [8]: #settings
 [9]: #about-the-use-for-registrations-field
 [10]: #configuring-fields-for-indications-and-orphan-designation