# Set Up the Localized Business Admin Library for Japan

Vault supports configuring Products and Studies for the intake and processing of Cases for Japan and compliant reporting to the PMDA. This includes the following:

* Adding Japan-reportable Product and Substance Registrations for Investigational and Postmarketing products
* Configuring regionally required information such as Registration Type, Japan Drug Codes, and Clinical Compound Numbers
  * Find the Registration Types in **Business Admin > Objects > Controlled Vocabularies** and filter to PMDA
* Specifying the [primary blinded investigational Product][2] for reporting blinded Products in blinded Study Arms

## Prerequisites

To take full advantage of the Japan and PMDA functionality in Vault, your Admin must <a href="/en/gr/01463/#pmda">review and enable PMDA-related features</a>.

## Add a Japan Product Registration

Complete the following steps to add a Japan Product Registration:

1. Go to **Business Admin > Objects > Products** and select the Product to which you want to add the registration.<br> If the Product is not set up, see Create Products in <a href="/en/gr/01215/#create-products">Manage Products</a>.
2. Expand the **Registrations** section, and then select **Create**.
3. On the **Create Product Registration** page, complete the fields.<br> For information on general data entry, see Add Product Registration Details in <a href="/en/gr/01215/#add-product-registration-details">Manage Products</a>. See <a href="#jpr-fields">the table below</a> for Japan-specific sections and fields.
4. Select **Save**.

### Japan Product Registration Fields  {#jpr-fields}

<table>
    <thead>
        <tr>
            <th>Section > Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Details > Organization</em></td>
            <td><p>Vault automatically populates this field with a reference link to the Organization on the parent <em>Product</em>.</p>
            <p>We recommend limiting this value to a maximum of 60 characters to respect the G.k.3.3 Name of Holder / Applicant data element specification on PMDA E2B(R3) reports. If this value is longer than 60 characters, Vault truncates it on the <em>Case Product Registration</em> record.</p></td>
        </tr>
        <tr>
            <td><em>Details > Registration Type</em></td>
            <td><p>Select the Registration Type.</p>
            <p>When reporting to the PMDA, this identifies Investigational from Postmarketing registrations.</p>
            <p>For a list of available Registration Types, navigate to <strong>Business Admin > Objects > Controlled Vocabularies</strong>. In the <strong>Agency</strong> filter, select the <strong>PMDA</strong> checkbox, and in the <strong>Type</strong> filter select the <strong>Registration Type</strong> checkbox.</p></td>
        </tr>
        <tr>
            <td><em>Details > Country</em></td>
            <td>Select <strong>Japan</strong>.</td>
        </tr>
        <tr>
            <td><em>Registration Details > Local Product Code</em></td>
            <td><p>Enter the region-specific product code.</p>
            <p>When setting up Postmarketing Product Registrations, the PMDA requires a Local Product Code. Do not populate this field for Investigational registrations.</p></td>
        </tr>
        <tr>
            <td><em>PMDA > Japan Product Code Type</em></td>
            <td>Select the classification of the local product code for Japan.</td>
        </tr>
        <tr>
            <td><em>PMDA > Clinical Compound Number</em></td>
            <td><p>Enter the Clinical Compound Number (CCN).</p>
            <p>When setting up Investigational Product Registrations, the PMDA requires a CCN. Do not populate this field for Postmarketing registrations.</p>
            <p>When reporting Study Cases for Clinical Trial Studies registered in Japan, <a href="#japan-localized-study-fields">enter the CCN on the Study Registration record</a> to export that value to the J2.12 Clinical Compound Number (CCN) data element of PMDA E2B(R3) reports.</p>
            </td>
        </tr>
        <tr>
            <td><em>PMDA > Product (Reported) Override</em></td>
            <td><p>Enter a value to map to <em>Case Product Registrations</em>. This value is used when processing foreign Cases for Japan, where the Case includes Products registered to Japan but the <em>Case Reporter Country</em> is not <em>Japan</em>.</p>
            <p>Upon PMDA E2B(R3) generation, Vault exports this value to the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element.</p>
            <p>This field supports the scenario when a foreign Case Product has multiple investigational registrations with studies conducted in Japan with the same Substance.</p></td>
        </tr>
        <tr>
            <td><em>PMDA > OTC Drug Classification</em></td>
            <td><p>Select the PMDA OTC Drug Risk category.</p>
            <p>Upon PMDA E2B(R3) generation, Vault exports this value to the J2.5.k Classification of OTC drugs data element.</p>
            </td>
        </tr>
        <tr>
            <td><em>PMDA > Dose Form</em></td>
            <td>Select the dose form.</td>
        </tr>
        <tr>
            <td><em>PMDA > Device/Product Generic Name</em></td>
            <td>Enter the generic name of the product to be reported to the PMDA.</td>
        </tr>
        <tr>
            <td><em>PMDA > JMDN Code</em></td>
            <td>When the generic name of the device or product is in the Japan Medical Device Nomenclature (JMDN), enter the associated JMDN code.</td>
        </tr>
        <tr>
            <td><em>PMDA > Device Classification 1</em></td>
            <td>Select the <em>Device Classification 1</em> of the device to be reported to the PMDA.</td>
        </tr>
        <tr>
            <td><em>PMDA > Device Classification 2</em></td>
            <td>Select the <em>Device Classification 2</em> of the device to be reported to the PMDA.</td>
        </tr>
        <tr>
            <td><em>PMDA > Device Classification 3</em></td>
            <td>Select the <em>Device Classification 3</em> of the device to be reported to the PMDA.</td>
        </tr>
        <tr>
            <td><em>PMDA > Regenerative Classification</em></td>
            <td>Select the <em>Regenerative Classification</em> of the device to be reported to the PMDA.</td>
        </tr>
    </tbody>
</table>

### Add a Japan Localized Substance

Complete the following steps to add a Japan Localized Substance to a Product Registration:

1. Go to **Business Admin > Objects > Products** and select the Product to which you want to add the Localized Substance.<br> If the Product is not set up, see Create Products in <a href="/en/gr/01215/#create-products">Manage Products</a>.
2. Expand the **Substances** section and then select the Substance to which you want to add the Localized Substance.<br> If the Substance is not set up, see Add Substances in <a href="/en/gr/01215/#add-substances">Manage Products</a>.
3. Expand the **Localizations** section and then select **Create**.
4. On the **Create Localized Substance** page, complete the fields. See <a href="#j-sub-fields">the table below</a> for Japan-specific sections and fields.
5. Select **Save**.

### <a id="j-sub-fields"></a>Japan Substance Fields

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Substance Name</em></td>
            <td>Enter the Japanese substance name.</td>
        </tr>
        <tr>
            <td><em>Substance</em></td>
            <td>The referenced <em>Substance</em>. Vault populates this field when you create the Localized Substance as a child object from the initial Substance.</td>
        </tr>
        <tr>
            <td><em>Local Product Code</em></td>
            <td>Enter the Japan local product code for the Substance.</td>
        </tr>
        <tr>
            <td><em>Localization</em></td>
            <td>Select <strong>(Japanese) Japan</strong>.</td>
        </tr>
    </tbody>
</table>

### Add a Japan Dose Form Code

Complete the following steps to add a three-letter E2B Code to a Dose Form. Users can select this code during Case data entry. When entered on Cases, **Dose Form Codes** are exported to the **G.k.4.r.9.1 Pharmaceutical Dose Form (free text)** data element of PMDA E2B(R3) reports.

1. Go to **Business Admin > Objects > Dose Form** and select the Dose Form to which you want to add the E2B Code.
2. Expand the **Localizations** section and then select **Create**.
3. On the **Create Localized Substance** page, complete the fields. See <a href="#jdf-fields">the table below</a> for Japan-specific sections and fields.
4. Select **Save**.

### <a id="jdf-fields"></a>Japan Dose Form Fields

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Name</em></td>
            <td>Enter a name for the Dose Form.</td>
        </tr>
        <tr>
            <td><em>Localization</em></td>
            <td>Select <strong>(Japanese) Japan</strong>.</td>
        </tr>
        <tr>
            <td><em>Dose Form</em></td>
            <td>The referenced <em>Dose Form</em>.</td>
        </tr>
        <tr>
            <td><em>E2B Code</em></td>
            <td>Enter the three-letter E2B Code for the Dose Form.</td>
        </tr>
    </tbody>
</table>

## <a id="add-japan-study-information"></a>Add Japan Study Information

When you add Study information, Vault populates PMDA information on Localized Study Cases for Japan.

### Add a Study

Complete the following steps to add a Study:

1. Go to **Business Admin > Objects > Studies** and refer to Add a Study in <a href="/en/gr/01216/#add-a-study">Manage Studies</a>.<br>If the Study is already in your Vault, go to the record.
2. On the **Create Study** page, complete the fields.<br> For information on general data entry, see Study Details Fields in <a href="/en/gr/01216/#study-details-fields">Manage Studies</a>.
   1. In the **Development Phase** field, select the development phase of the Study. Upon PMDA E2B(R3) generation, Vault exports this value to the **J2.13.r.3 Development phase** data element.
3. Select **Save**.

### Add a Japan Localized Study

Complete the following steps to add a Localized Study for Japan:

1. Go to **Business Admin > Objects > Studies** and open the Study to which you want to add a Localized Study.
2. Expand the **Localizations** section and then select **Create**.
3. On the **Create Localized Study** page, complete the fields. See <a href="#japan-localized-study-fields">the table below</a> for Japan-specific sections and fields.
4. Select **Save**.

### <a id="japan-localized-study-fields"></a>Japan Localized Study Fields

<table>
    <thead>
        <tr>
            <th>Section > Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Details > Localization</em></td>
            <td>Select <strong>(Japanese) Japan</strong>.</td>
        </tr>
        <tr>
            <td><em>Details > Study Name</em></td>
            <td>Enter the Japanese Study name.</td>
        </tr>
        <tr>
            <td><em>Details > Study Type</em></td>
            <td>This value is populated based on the parent <em>Study</em>.</td>
        </tr>
        <tr>
            <td><em>PMDA > Number of Clinical Trial Notifications</em></td>
            <td><p>Enter the number of clinical trial notifications submitted to the PMDA for this study.</p>
            <p>Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.1 Number of CTN data element.</p>
            </td>
        </tr>
        <tr>
            <td><em>PMDA > Existence of Subjects</em></td>
            <td><p>Select <strong>Yes</strong> or <strong>No</strong> to indicate whether subjects are present in this study.</p>
            <p>Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.4 Existence of subjects data element.</p>
            </td>
        </tr>
        <tr>
            <td><em>PMDA > Target Disease</em></td>
            <td><p>Describe the disease being studied.</p>
            <p>Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.2 Study indications data element.</p>
            </td>
        </tr>
        <tr>
            <td><em>PMDA > Dates of Clinical Trial Notification</em></td>
            <td>Using the format <code>YYYYY/MM/DD</code>, enter the date the Clinical Trial Notification was submitted to PMDA. Comma-separate multiple dates.</td>
        </tr>
        <tr>
            <td><em>PMDA > Primary Investigational Product Category</em></td>
            <td>Enter the category of the primary study product described in the Clinical Trial Notification.</td>
        </tr>
        <tr>
            <td><em>PMDA > Study Device Classification</em></td>
            <td>For device clinical trials, select the device classification of the primary study product.</td>
        </tr>
    </tbody>
</table>

## <a id="primary-inv-prod"></a>Specify the Primary Investigational Product for Blinded Study Arm Products

For blinded Products in blinded Study Arms, you can specify the primary blinded investigational Product when multiple investigational Products are included in the blinded Product, which Vault uses to calculate reportability to the PMDA. For more information, see Blinded Study Product Reporting in <a href="/en/gr/696896/#blinded-study-prod-reporting">Report to the PMDA</a>.

Add primary blinded investigational Products to _Study Product Placeholders_ as follows:

1. Navigate to a **Study** record at **Business Admin > Objects > Studies**.
2. <a href="/en/gr/840046/#add-a-study-arm-product">Add a Study Arm Product</a> or navigate to an existing record under **Study Arm Products**.
3. Click **Edit** on the **Study Arm Product** record.
4. In the **Blinded Name** field, create a **Study Product Placeholder** record or select an existing **Study Product Placeholder** record to edit.
5. In the **Primary Blinded Investigational Product** field, select a Product. 
6. Select **Save**.

## Add a Japan Study Registration

Complete the following steps to add a Study Registration for Japan:

1. Go to **Business Admin > Objects > Studies** and open the Study to which you want to add a Japan Study Registration.
2. Expand the **Registrations** section and then select **Create**.
3. On the **Create Study Registration** page, complete the fields.<br> For information on general data entry, see Add a Study Registration in <a href="/en/gr/01216/#add-a-study-registration">Manage Studies</a>.
   1. In the **Clinical Compound Number** field, enter the Japan Clinical Compound Number (CCN) of the investigational drug. This field appears only if the **Country** field is set to **Japan**. When reporting Study Cases for Clinical Trial Studies registered in Japan, Vault populates this value in the **J2.12 Clinical Compound Number (CCN)** data element of PMDA E2B(R3) reports.<br>If this field is blank, Vault maps the CCN of the primary Case Product Registration from the **Local Reporting Details** section of the Case.
4. Select **Save**.

## Create Japan Organizations (Non-PMDA Only)

Vault includes the Japan regulatory agency PMDA. If you prepare submissions for the PMDA only, you can skip these steps. For other Japan reporting destinations, such as Partner Distributions, create an Organization.

1. Go to **Business Admin > Objects > Organizations** and <a href="/en/gr/01213/">create the Organization</a>.<br>If the Organization is already in your Vault, go to the record.
2. On the Organization, set the **Localization** field to Japan.<br>You may need to update the **Organization** layout to add this field.
3. Under the Organization, add a Localized Organization child record.<br>You may need to update the **Organization** layout to add the **Localized Organization** related object section.
4. <a href="/en/gr/01256/">Set up reporting rules</a> for the destination organization.<br>You must set up reporting rules to automatically generate Localized Japan Cases when reporting obligations are evaluated.

## Set Up Localizations

You can configure **Localization** records to meet specific reporting needs and reduce manual effort when working on Domestic and Localized Cases. For the Japan Localization, you can configure the following behaviors:

* <a href="/en/gr/696910/#cpr-section">Auto-population of reportable Case Product Registrations</a> to expedite data entry for the J2 data elements of PMDA E2B(R3) reports.
* <a href="/en/gr/696910/#assessments-section">Generate Localized Case Assessments and Expectedness for all Case Product Registrations</a> on the Localized Case. This feature allows for calculating Due Dates at the Transmission level or for each Localized Case Assessment.

### Manage Localizations

To manage **Localization** records, go to **Business Admin > Objects > Localizations**. When editing a record, reference the following table when populating fields.

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Localization Type</em></td>
            <td><p>The available Localization Types are Global and Local. The Localization Type impacts whether Inbox Items and Cases are processed as <a href="/en/gr/01287/">Global</a>, <a href="/en/gr/01168/">Domestic</a>, or <a href="/en/gr/01290/">Localized</a>.</p> 
            <p>Your Admin can configure your Vault to <a href="/en/gr/01329/#enable-vault-system-settings">auto-set Inbox Item Localization by Reporter Country</a>.</p></td>
        </tr>
        <tr>
            <td><a id="local-scope"></a><em>Localization Scope</em></td>
            <td><p>Localization Scope manages which fields are available for dual-language Domestic Case processing. Leave this field blank for the Localization Scope to include all fields. Otherwise, you can set the scope to only Narratives, Company Comments, or both.</p>
            <p>If configured, Vault exports the localized values for Company Comments and Narratives in E2B formats.</p></td>
        </tr>
        <tr>
            <td><a id="assessment-generation"></a><em>Assessment Generation</em></td>
            <td><p>This field enables Localized Case Assessment generation based on Japanese Case Product Registrations. This feature is available only when reporting to the PMDA.</p>
                <p>Select how Vault generates Case Assessments as follows:</p>
                    <ul>
                        <li>Leave this field blank to generate Domestic or Localized Case Assessments and Expectedness for each Case Product and Adverse Event pair.
                            <ul>
                                <li>With this setting, when you run the <em>Evaluate Reporting Obligations</em> action on reportable Domestic and Localized Cases in this Localization, Vault generates Transmissions and populates Due Dates on <em>Transmission</em> records. Due Date calculations are affected by the setting in the <a href="#localized-calc"><em>Localized Due Date Calculation</em></a> field.</li>
                            </ul>
                        </li>
                        <li>Select <strong>Localized Assessments for Case Product Registrations</strong> to generate Localized Case Assessments and Expectedness for each Case Product Registration and Adverse Event pair. This option is supported only when working on Cases that are reportable to the PMDA.
                            <ul>
                                <li>With this setting, when you run the <em>Evaluate Reporting Obligations</em> action on reportable Localized Cases in Japan, Vault does not generate Transmissions. Instead, Vault populates the Due Dates and Due in Days values for each reportable <em>Localized Case Assessment</em>. Due Date calculations are affected by the setting in the <a href="#localized-calc"><em>Localized Due Date Calculation</em></a> field.</li>
                                <li>You must use this setting to calculate Due Date and Due in Days values on Localized Case Assessments from Japan Domestic Cases. The <em>Calculate Due Dates on LCA</em> action generates these calculations.</li>
                                <li>With this setting, on Domestic Cases for Japan, <em>Expectedness</em> records are not generated for Case Products with registrations that are reportable to the PMDA. Instead, Expectedness evaluations appear on <em>Localized Case Assessment</em> records. At the Case-level, Expectedness is set using the most reportable evaluation across all non-PMDA Expectedness records and Localized Case Assessments from the Japan Localized Case. For information on how Vault evaluates the Most Reportable Case Product and Case Assessment, see <a href="/en/gr/01249/#most-reportable-case-product-and-case-assessment">Reporting Rules Product Selection</a>.
                        </li>
                        <li>For more information on Localized Case Assessments, see <a href="/en/gr/696910/#assessments-section">Complete Intake and Process Cases for the PMDA</a>.</li>
                            </ul>
                    </li>
                    </ul>
                </td>
        </tr>
        <tr>
            <td><a id="localized-calc"></a><em>Localized Due Date Calculation</em></td>
            <td>When you set the <em>Assessment Generation</em> field to <em>Localized Assessments for Case Product Registrations</em>, you can select the method for calculating Due Dates on Localized Case Assessments for Japan as follows:
            <ul>
                <li>Select <strong>Global Case - New Info Date</strong> to calculate the Due Date based on the New Info Date and Due in Days values.
                    <ul>
                        <li>If the <em>New Info Date</em> field is blank, Vault uses the Receipt Date.
                        </li>
                    </ul>
                </li>
                <li>Select <strong>Localized Case - Local Awareness Date</strong> to calculate the Due Date based on the Local Awareness Date and Due in Days values.
                    <ul>
                        <li>If the <em>Local Awareness Date</em> field is blank, Vault uses the New Info Date, if available, or the Receipt Date.
                        </li>
                    </ul>
                </li>
            </ul>
            </td>
        </tr>
    </tbody>
</table>

## Controlled Vocabulary Types

Vault includes <a href="/en/gr/01195/">_Controlled Vocabularies_</a> that contain standard ICH-based terminologies used to describe or code information on a _Case_. The _Controlled Vocabulary_ types listed in this section are specific to reporting to the PMDA.

### Completeness {#completeness}

This Controlled Vocabulary type maps to the **Completeness** field for entering data about the case completeness on each reporting Case. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.7.1 Completion flag</strong>.

### Development Phase {#development-phase}

This Controlled Vocabulary type maps to the **Development Phase** field to determine which options are available in that field for entering study information. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.13.r.3 Development phase</strong>.

### Literature Classification {#literature-classification}

This Controlled Vocabulary type maps to the **Literature Classification** field on the document for classifying the literature document. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.17.r Classification of trial/research</strong>.

### OTC Drug Channel {#otc-drug-channel}

This Controlled Vocabulary type maps to the **OTC Drug Channel** field for entering data about from where the reported OTC drug obtained. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.6.k Obtaining channels for OTC drugs</strong>.

### OTC Drug Classification {#otc-drug-classification}

This Controlled Vocabulary type maps to the **OTC Drug Classification** field for entering data about the classification of OTC drugs. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.5.k Classification of OTC drugs</strong>.

### PMDA Reporting Category {#pmda-reporting-category}

This Controlled Vocabulary type maps to the **PMDA Reporting Category** field for entering data about the reporting category for PMDA. This Controlled Vocabulary maps to PMDA E2B (R3) data element <strong>J2.1a PMDA Reporting Category</strong>.

### Registration Type {#registration-type}

This Controlled Vocabulary type determines which options are available in the **Registration Type** field for entering registration information while adding a product to the Product Library.

The **Registration Category** field is specific to the Registration Type Controlled Vocabulary.<br>
You can categorize a Registration Type as either Investigational or Marketing. The Registration Category is considered during <a href="/en/gr/01247/">cross reporting evaluation</a>.

## Special Report Classification and Reporting Rules

Vault supports coding cases with the following PMDA special report classifications:

* Safety Measures Report
* Research Report

The **Special Report Classification** reporting rule parameter is evaluated when Cases may be reportable to the PMDA. If this parameter is set to "No", the rule is evaluated when the **Special Report Classification** field is blank.

When evaluating reporting rules, Cases with Special Report Classification values are always excluded unless this parameter is specified in the Safety Rule Set.

For general information on reporting rule parameters, see <a href="/en/gr/01250/">Reporting Rule Parameter Reference</a>.

Optionally, contact Veeva Managed Services to have additional options created for this field. This is useful in situations when Cases should be reported to certain destinations only.

[1]: #japan-localized-study-fields
[2]: #primary-inv-prod