# PMDA E2B(R3) Case Import

Safety enables quick upload and import of PMDA E2B(R3) files to create _Inbox Items_ for Japan _Domestic Cases_, supporting all information required to report to the PMDA. This capability includes all the same functionality as with ICH E2B(R2) or (R3) import, including uploading PMDA E2B(R3) XML files to your _Library_ to <a href="/en/lr/01139/#aer">generate _Inbox Items_ for _Adverse Event Report_ classified documents</a>.

For general information on upload, import, and mapping, see <a href="/en/lr/01135/">Import an Inbox Item</a>.

Because _Inbox Items_ do not include all of the same fields as _Cases_, some fields and child records do not appear until after _Case_ promotion. This includes data that maps to the following Japan-specific objects:

* <a href="/en/lr/696910/#case-product-registration-section">_Case Product Registration_</a>
* <a href="/en/lr/696910/#local-reporting-details-section">_Local Reporting Details_</a>
* <a href="/en/lr/696910/#case-comments-section">_Case Comments_</a>

After _Case_ promotion, Vault generates _Domestic Cases_ and _Localized Cases_ for Japan. Data is mapped as described in [PMDA E2B(R3) Data Element Field Mapping][2]. For more information on processing _Cases_, see <a href="/en/lr/696910/#case-processing">Complete Intake and Process Cases for the PMDA</a>.

## Prerequisites

To import PMDA E2B(R3) files, your Admin must configure the following Vault Safety General Settings:

* Enable _Localization-based Mapping on Import_. For more information, see <a href="/en/lr/01335/">Enable Local Case Import</a>.
* Enable the _Enable auto-set Inbox Item Localization by Reporter Country_ setting. For more information, see <a href="/en/lr/01329/">Enable Domestic Case Processing for Agency Jurisdictions</a>.

For general prerequisites for importing an _Inbox Item_ from an E2B file, see <a href="/en/lr/01135/#prerequisites">Import an Inbox Item</a>.

## Verifying the PMDA E2B(R3) XML File

When you run the _Create Inbox Item from Document_ action on an imported XML file, Vault verifies the file includes the following required elements to create a Japan _Domestic Case_:

* The PMDA E2B(R3) file must include a _J2.1a_ data element with the value "2.16.840.1.113883.3.989.5.1.3.2.1.1".
* The primary _Reporter Country_ in the file must be "Japan".

If the file contains all the required elements, Vault maps all data and documents to the appropriate objects, fields, and documents for a Japan _Domestic Case_. To learn more about Japan case intake, see <a href="/en/lr/696910/#japan-case-intake">Complete Intake and Process Cases for the PMDA</a>.

If the file does not contain all the required elements to create an _Inbox Item_ for Japan, Vault imports the file using the <a href="/en/lr/01134/#e2br3">ICH E2B(R3) logic</a> and displays a warning message. The CSV rendition of the E2B file contains only ICH elements. For more information about the CSV rendition, see <a href="/en/lr/01135/#about-the-csv-renditions-of-imported-e2b-files">Import an Inbox Item</a>.

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      <p><strong>Note</strong>: If the D.10.4 Body Weight (kg) of Parent or D.10.5 Height (cm) of Parent data element values in the file are missing or not valid, Vault ignores the values on import. After <em>Case</em> promotion, in the <em>Parent Information</em> field in the <em>Patient</em> section, Vault links <em>Parent Information</em>. This is a known limitation that will be addressed in a future release.</p>
    </div>
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## Working with Imported Inbox Items

When you create an _Inbox Item_ from a PMDA E2B(R3) file and the primary _Reporter Country_ is "Japan", Vault sets the _Localization_ field of the _Inbox Item_ to "Japanese (Japan)".

Imported data appears in the _Source Data_ panes of _Inbox Items_. For more information about the _Source Data_ pane, see <a href="/en/lr/01135/#import-source-data-pane">Import an Inbox Item</a>.

In the _Details_ section of _Inbox Items_, these J2 data elements appear in the _Source Data_ pane:

* _J2.1a PMDA Reporting Category_
* _J2.1b PMDA Identification Number_
* _J2.2.1 Day 0 of Reporting Timeframe for PMDA_
* _J2.3 Flag for Immediate Report_
* _J2.7.1 Completion flag_

In the _Products_ section of _Inbox Items_, these J2 data elements appear in the _Source Data_ pane:

* _J2.4.k License Category of New Drug_
* _J2.5.k Classification of OTC drugs_
* _J2.6.k Obtaining channels for OTC drugs_

If the imported _Inbox Item_ is for a Clinical Trial _Study Case_ for _PMDA Reporting Category_ DA, DB, DC, or DD, _J2.14.i Expectedness_ values appear in the _Source Data_ pane, but Vault does not import _Localized Case Assessment_ or _Localized Case Assessment Results_ to the _Inbox Item_. After _Case_ promotion, Vault evaluates expectedness as described in <a href="/en/lr/696910/#expectedness">Complete Intake and Process Cases for the PMDA</a>.

Other fields that do not appear in _Source Data_ panes on _Inbox Items_ can be viewed in the CSV renditions of imported PMDA E2B(R3) files. For more information, see <a href="/en/lr/01135/#csv-rendition">Import an Inbox Item</a>.

## <a id="record-gen"></a>Record Generation on Case Promotion

When you promote an _Inbox Item_ to a Japan _Domestic Case_, as with promoting manually created _Inbox Items_, Vault generates a _Case_ with PMDA-specific records and field values. Depending on your selections on the _Inbox Item_ and the data in the imported PMDA E2B(R3) file, Vault generates some records, described in this section, using the information in your _Product_ library, by overwriting imported information, or by creating placeholder records using information from the imported file.

### Case Product Registrations

After _Case_ promotion, Vault generates a _Case Product Registration_ record for each _J2.4.k License Category of New Drug_ data element found in the _G.k. Drug(s) Information_ section of the PMDA E2B(R3) file.

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      <p><strong>Note</strong>: If you manually override imported <em>Product</em> data on an <em>Inbox Item</em>, Vault considers the populated value and not the imported value during <em>Case</em> promotion.</p>
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For _Case Products_ with PMDA-reportable _Product Registrations_, Vault generates _Case Product Registration_ records and populates the data based on the _Product_ library, overwriting imported information.

For _Case Products_ without PMDA-reportable _Product Registrations_, if the imported file includes product registration data, Vault generates placeholder _Case Product Registration_ records and populates the data from the file. When the _Product_ selected on the _Inbox Item_ is not a _Company Product_, the placeholder is generated for an _External Product_. If you add a PMDA-reportable _Product Registration_ to a placeholder _Case Product Registration_ record, Vault overwrites the existing details with the information in the _Product_ library.

For information on _Case Product Registration_ fields, see <a href="/en/lr/696910/#case-product-registration-section">Complete Intake and Process Cases for the PMDA</a>.

### Local Reporting Details

After _Case_ promotion, Vault generates _Local Reporting Details_ as described in <a href="/en/lr/696910/#local-reporting-details-section">Complete Intake and Process Cases for the PMDA</a>.

During record creation, Vault populates the _Primary Case Product_ field with the _Case Product_ that has the _Rank_ field set to "1". If the _Primary Case Product_ has a _Product Registration_, Vault populates the _Primary Case Product Registration_ field. If there is no _Case Product_ ranked as "1", Vault does not populate the _Primary Case Product_ or _Primary Case Product Registration_ fields.

### Localized Case Assessments and Localized Case Assessment Results

After _Case_ promotion, for each _Case Product_ with a PMDA-reportable _Product Registration_, Vault generates _Localized Case Assessment_ and _Localized Case Assessment Results_ based on the imported _Adverse Event_ and Vault-mapped _Case Product Registrations_.

Vault does not generate _Localized Case Assessments_ and _Localized Case Assessment Results_ for placeholder _Case Product Registration_ records. When you add a PMDA-reportable _Product Registration_ to a placeholder _Case Product Registration_ record, Vault then generates the _Localized Case Assessment_ and _Localized Case Assessment Result_ records.

Vault evaluates expectedness as described in <a href="/en/lr/696910/#expectedness">Complete Intake and Process Cases for the PMDA</a>.

## Merge to In-Flight and Promote to Follow-Up Cases

For imported PMDA E2B(R3) _Inbox Items_, Vault supports both merging to _In-flight Cases_ and promoting to _Follow-up Cases_ through the <a href="/en/lr/826980/#complete-the-inbox-item-to-case-compare-page">_Inbox Item to Case Compare_ page</a>. For both scenarios, Vault maps all localized and J2 data element information that didn't appear on the _Inbox Item_ to the _Case_.

### Case Products

If an _Inbox Item_ includes a new or changed _Product_, Vault generates records on the In-flight or _Follow-up Case_ as described in [Record Generation on Case Promotion][1].

### Local Reporting Details

When comparing _Inbox Items_ to matched _Cases_, Vault considers _Local Reporting Details_ records a match when they have the same _Report UID_ and _PMDA Reporting Category_.

* If there are matching _Local Reporting Details_ or the _Inbox Item_ includes a new _Local Reporting Details_ record, Vault generates the _Local Reporting Details_ and _Localized Case Comments_ based on the _Inbox Item_. Vault does not include the records from the matched _Case_.
* If there are multiple _Case Product Registration_ records for the primary _Case Product_ on the matched _Case_, Vault selects the most recently created _Product Registration_.
* If an _Inbox Item_ does not include a _Local Reporting Details_ record on the matched _Case_, Vault keeps the existing _Local Reporting Details_ and _Localized Case Comments_ records.

## <a id="field-mapping"></a>PMDA E2B(R3) Data Element Field Mapping

This section covers how Vault imports the data specific to processing _Domestic Cases_ and _Localized Cases_ that are reportable to the PMDA. For information on the other field values imported through a PMDA E2B(R3) file and for general information on ICH import field mapping, see <a href="/en/lr/01134/">E2B Case Import Data Mapping</a>.

### E2B Data Elements Mapped to Case Product Registrations

For general information on _PMDA Case Product Registration_ fields, see <a href="/en/lr/696910/#pmda-case-product-registration-fields">Complete Intake and Process Cases for the PMDA</a>.

<table>
    <thead>
        <tr>
            <th>E2B Header</th>
            <th>E2B Data Element Name</th>
            <th>Case Product Registration Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>J2</td>
            <td>J2.4.k License Category of New Drug (新医薬品等の状況区分)</td>
            <td><p>Populates the <em>Registration Type</em> field.</p>
            <p>Vault maps the E2B Code from <em>Controlled Vocabulary</em> records with the <em>Type</em> set to "PMDA Reporting Category".</p></td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.5.k Classification of OTC drugs (一般用医薬品等のリスク区分等)</td>
            <td>Populates the <em>OTC Drug Classification</em> field when the <em>Case Product Registration</em> is for a <em>Company Product</em>.</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.6.k Obtaining channels for OTC drugs (一般用医薬品等の入手経路)</td>
            <td>Populates the <em>OTC Drug Channel</em> field when the <em>Case Product Registration</em> is for a <em>Company Product</em>.</td>
        </tr>
        <tr>
            <td>G.k</td>
            <td>G.k.2.2 Medicinal Product Name as Reported by the Primary Source (第一次情報源により報告された医薬品名)</td>
            <td><p>Populates the first 12 characters in the <em>Local Product Code</em> field. During import, Vault truncates characters that exceed the 12-character limit.</p>
            <p>For imported <em>Cases</em>, Vault does not automatically populate the <em>Japan Product Code Type</em> field based on the <em>Product Registration</em> in the <em>Product</em> library. You must manually set the field to <em>J-Drug Code</em> for Vault to map the first seven (7) digits of the <em>Local Product Code</em> to the <em>G.k.2.3.r.1 Substance / Specified Substance Name</em> data element when exporting PMDA E2B(R3) reports.</p></td>
        </tr>
        <tr>
            <td>G.k</td>
            <td>G.k.3.1 Authorisation / Application Number (承認／申請番号)</td>
            <td>Populates the <em>Registration Number</em> field when the <em>Case Product Registration</em> is for a <em>Company Product</em>.</td>
        </tr>
        <tr>
            <td>G.k</td>
            <td>G.k.3.2 Country of Authorisation / Application (承認／申請国)</td>
            <td>Populates the <em>Registration Country</em> field when the <em>Case Product Registration</em> is for a <em>Company Product</em>.</td>
        </tr>
        <tr>
            <td>G.k</td>
            <td>G.k.3.3 Name of Holder / Applicant (承認の取得者／申請者の名称)</td>
            <td>Populates the <em>Registration Holder/Applicant</em> field when the <em>Case Product Registration</em> is for a <em>Company Product</em>.</td>
        </tr>
    </tbody>
</table>

### E2B Data Elements Mapped to Local Reporting Details

For general information on _Local Reporting Details_ fields, see <a href="/en/lr/696910/#local-reporting-details-section-fields">Complete Intake and Process Cases for the PMDA</a>.

<table>
    <thead>
        <tr>
            <th>E2B Header</th>
            <th>E2B Data Element Name</th>
            <th>Local Reporting Details Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>N.2.R</td>
            <td>N.2.r.1 Message Identifier (メッセージ識別子)</td>
            <td>Populates the <em>Report UID</em> field excluding the first two (2) hyphenated parts of the value. For example, if the value is "JP-VEEVA-000014AA", Vault populates "000014AA".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.1a PMDA Reporting Category (識別番号（報告分類))</td>
            <td>Populates the <em>E2B Code</em> on the <em>Controlled Vocabulary</em> when the <em>Type</em> is "PMDA Reporting Category".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.1b PMDA Identification Number (識別番号（番号))</td>
            <td>Populates the <em>Destination Case ID</em> field.</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.3 Flag for Immediate Report (即時報告フラグ)</td>
            <td><p>Populates the <em>Immediate Report Type</em> field.</p>
            <p>If the value of this element is "1", Vault populates "System (E2B)".</p></td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.7.1 Completion flag (完了、未完了区分)</td>
            <td><p>Populates the <em>Completeness</em> field.</p>
            <p>If the value in this data element is "Active", Vault populates "Incomplete". If the value is "Completed", Vault populates "Complete".</p></td>
        </tr>
    </tbody>
</table>

### E2B Data Elements Mapped to Localized Case Comments

For general information on _Localized Case Comments_ fields, see <a href="/en/lr/696910/#case-comments-section">Complete Intake and Process Cases for the PMDA</a>.

<table>
    <thead>
        <tr>
            <th>E2B Header</th>
            <th>E2B Data Element Name</th>
            <th>Localized Case Comment Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>J2</td>
            <td>J2.2.2 Comments on Initial Date for Reporting (報告起算日に関するコメント)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Receipt Date Comments".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.7.2 Comments on Incompletion (未完了に関するコメント)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Comments on Completeness".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.8.2 Reason for Downgrading Report (報告対象外の理由)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Downgrade Reason".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.9 Retrospective analysis of infections (感染症の遡及調査)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Retrospective analysis of infections".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.10 Action to be taken (今後の対応)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Future Actions".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.11 Other references (その他参考事項等)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Other References".</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.16 Overview of the report (報告内容の要点)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Report Overview".</td>
        </tr>
        <tr>
            <td>H</td>
            <td>H.4 Sender's Comments (送信者の意見)</td>
            <td>Populates the <em>Comments Text</em> field when the <em>Comments Label</em> value is "Company Comments".</td>
        </tr>
    </tbody>
</table>

### Other E2B Data Element Mapping

For general information on _Localized Case Comments_ fields, see <a href="/en/lr/696910/#case-comments-section">Complete Intake and Process Cases for the PMDA</a>.

<table>
    <thead>
        <tr>
            <th>E2B Header</th>
            <th>E2B Data Element Name</th>
            <th>Populated Field and Object</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>J2</td>
            <td>J2.2.1 Day 0 of Reporting Timeframe for PMDA (報告起算日)</td>
            <td>Populates the <em>Local Awareness Date</em> field in the <em>Details</em> section.</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.15.r Country of publication (公表国)</td>
            <td>For each document included in the <em>C.4.r Literature</em> section of the PMDA E2B(R3) file, Vault creates a <em>Document</em> record when the associated document type is <em>Case > Source > Literature</em>. Vault maps the value in this data element to the <em>Publication Country</em> field.</td>
        </tr>
        <tr>
            <td>J2</td>
            <td>J2.17.r Classification of trial/research (試験/研究の分類)</td>
            <td>For each qualifying document identified in the <em>J2.15.r Country of Publication</em> data element, Vault maps the value in this data element to the <em>Literature Classification</em> field of the <em>Document</em> record.</td>
        </tr>
        <tr>
            <td>C.1.6.1.r</td>
            <td>C.1.6.1.r.1 Documents Held by Sender (送信者が保有している資料)</td>
            <td>For each qualifying document identified in the <em>C.1.6 Additional Available Documents Held by Sender</em> data element, Vault maps the value in this data element to the <em>Attachment Description</em> field of the <em>Localized Case Document</em> record.</td>
        </tr>
        <tr>
            <td>C.4.r</td>
            <td>C.4.r.1 Literature Reference(s) (引用文献)</td>
            <td>For each qualifying document identified in the <em>C.4.r Literature Reference(s)</em> data element, Vault maps the value in this data element to the <em>Reference Text</em> field of the <em>Localized Case Document</em> record.</td>
        </tr>
        <tr>
            <td>G.k</td>
            <td>G.k.2.2 Medicinal Product Name as Reported by the Primary Source (第一次情報源により報告された医薬品名)</td>
            <td><p>If the G.k section includes a <em>J2.4.k License Category of New Drug</em> data element, Vault considers the product a <em>Company Product</em> and maps the value to <em>Local Product Code</em> field of the <em>Case Product Registration</em>.</p>
            <p>If the section does not include a <em>J2.4.k License Category of New Drug</em> data element, Vault considers the product an <em>External Product</em> and maps the value to the <em>Local MPID</em> field on the <em>Localized Case Product</em> record.</p></td>
        </tr>
        <tr>
            <td>H</td>
            <td>H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information (臨床経過、治療措置、転帰及びその他の関連情報を含む症例の記述情報)</td>
            <td>The text from the <em>Narrative Text</em> field on the Japan <em>Localized Case</em>, to a limit of 100,000 characters.</td>
        </tr>
    </tbody>
</table>

[1]: #record-gen
[2]: #field-mapping