Learn how Vault Safety imports PMDA E2B(R3) files to Inbox Items, supporting all information required to report to the PMDA.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About PMDA E2B(R3) Case Import
Vault Safety enables quick upload and import of PMDA E2B(R3) files to create Inbox Items for Japan Domestic Cases. 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 using the Case › Source › Adverse Event Report document type and then generating Inbox Items with the Create Inbox Item from Document action.
For general information on upload, import, and mapping, see Import an Inbox Item.
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:
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. For more information on processing Cases, see Complete Intake and Process Cases for the PMDA.
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 Enable Local Case Import.
- Enable auto-select Inbox Item Localization by Reporter Country. For more information, see Enable Domestic Case Processing for Agency Jurisdictions.
For general prerequisites for importing an Inbox Item from an E2B file, see Import an Inbox Item.
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 Complete Intake and Process Cases for the PMDA.
If the file does not contain all the required elements to create an Inbox Item for Japan, Vault imports the file using the ICH E2B(R3) logic and displays a warning message. The CSV rendition of the E2B file contains only ICH elements. For more information about the CSV rendition, see Import an Inbox Item.
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 Import an Inbox Item.
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 Complete Intake and Process Cases for the PMDA.
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 Import an Inbox Item.
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.
Note: If you manually override imported Product data on an Inbox Item, Vault considers the populated value and not the imported value during Case promotion.
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 Complete Intake and Process Cases for the PMDA.
Local Reporting Details
After Case promotion, Vault generates Local Reporting Details as described in Complete Intake and Process Cases for the PMDA.
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 Complete Intake and Process Cases for the PMDA.
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 Inbox Item to Case Compare page. 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.
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.
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 E2B Case Import Data Mapping.
E2B Data Elements Mapped to Case Product Registrations
For general information on PMDA Case Product Registration fields, see Complete Intake and Process Cases for the PMDA.
| E2B Header | E2B Data Element Name | Case Product Registration Field |
|---|---|---|
| J2 | J2.4.k License Category of New Drug (新医薬品等の状況区分) | Populates the Registration Type field. Vault maps the E2B Code from Controlled Vocabulary records with the Type set to "PMDA Reporting Category". |
| J2 | J2.5.k Classification of OTC drugs (一般用医薬品等のリスク区分等) | Populates the OTC Drug Classification field when the Case Product Registration is for a Company Product. |
| J2 | J2.6.k Obtaining channels for OTC drugs (一般用医薬品等の入手経路) | Populates the OTC Drug Channel field when the Case Product Registration is for a Company Product. |
| G.k | 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) | Populates the first 12 characters in the Local Product Code field. During import, Vault truncates characters that exceed the 12-character limit. For imported Cases, Vault does not automatically populate the Japan Product Code Type field based on the Product Registration in the Product library. You must manually set the field to J-Drug Code for Vault to map the first seven (7) digits of the Local Product Code to the G.k.2.3.r.1 Substance / Specified Substance Name data element when exporting PMDA E2B(R3) reports. |
| G.k | G.k.3.1 Authorisation / Application Number (承認／申請番号) | Populates the Registration Number field when the Case Product Registration is for a Company Product. |
| G.k | G.k.3.2 Country of Authorisation / Application (承認／申請国) | Populates the Registration Country field when the Case Product Registration is for a Company Product. |
| G.k | G.k.3.3 Name of Holder / Applicant (承認の取得者／申請者の名称) | Populates the Registration Holder/Applicant field when the Case Product Registration is for a Company Product. |
E2B Data Elements Mapped to Local Reporting Details
For general information on Local Reporting Details fields, see Complete Intake and Process Cases for the PMDA.
| E2B Header | E2B Data Element Name | Local Reporting Details Field |
|---|---|---|
| N.2.R | N.2.r.1 Message Identifier (メッセージ識別子) | Populates the Report UID field excluding the first two (2) hyphenated parts of the value. For example, if the value is "JP-VEEVA-000014AA", Vault populates "000014AA". |
| J2 | J2.1a PMDA Reporting Category (識別番号（報告分類)) | Populates the E2B Code on the Controlled Vocabulary when the Type is "PMDA Reporting Category". |
| J2 | J2.1b PMDA Identification Number (識別番号（番号)) | Populates the Destination Case ID field. |
| J2 | J2.3 Flag for Immediate Report (即時報告フラグ) | Populates the Immediate Report Type field. If the value of this element is "1", Vault populates "System (E2B)". |
| J2 | J2.7.1 Completion flag (完了、未完了区分) | Populates the Completeness field. If the value in this data element is "Active", Vault populates "Incomplete". If the value is "Completed", Vault populates "Complete". |
E2B Data Elements Mapped to Localized Case Comments
For general information on Localized Case Comments fields, see Complete Intake and Process Cases for the PMDA.
| E2B Header | E2B Data Element Name | Localized Case Comment Field |
|---|---|---|
| J2 | J2.2.2 Comments on Initial Date for Reporting (報告起算日に関するコメント) | Populates the Comments Text field when the Comments Label value is "Receipt Date Comments". |
| J2 | J2.7.2 Comments on Incompletion (未完了に関するコメント) | Populates the Comments Text field when the Comments Label value is "Comments on Completeness". |
| J2 | J2.8.2 Reason for Downgrading Report (報告対象外の理由) | Populates the Comments Text field when the Comments Label value is "Downgrade Reason". |
| J2 | J2.9 Retrospective analysis of infections (感染症の遡及調査) | Populates the Comments Text field when the Comments Label value is "Retrospective analysis of infections". |
| J2 | J2.10 Action to be taken (今後の対応) | Populates the Comments Text field when the Comments Label value is "Future Actions". |
| J2 | J2.11 Other references (その他参考事項等) | Populates the Comments Text field when the Comments Label value is "Other References". |
| J2 | J2.16 Overview of the report (報告内容の要点) | Populates the Comments Text field when the Comments Label value is "Report Overview". |
| H | H.4 Sender's Comments (送信者の意見) | Populates the Comments Text field when the Comments Label value is "Company Comments". |
Other E2B Data Element Mapping
For general information on Localized Case Comments fields, see Complete Intake and Process Cases for the PMDA.
| E2B Header | E2B Data Element Name | Populated Field and Object |
|---|---|---|
| J2 | J2.2.1 Day 0 of Reporting Timeframe for PMDA (報告起算日) | Populates the Local Awareness Date field in the Details section. |
| J2 | J2.15.r Country of publication (公表国) | For each document included in the C.4.r Literature section of the PMDA E2B(R3) file, Vault creates a Document record when the associated document type is Case > Source > Literature. Vault maps the value in this data element to the Publication Country field. |
| J2 | J2.17.r Classification of trial/research (試験/研究の分類) | For each qualifying document identified in the J2.15.r Country of Publication data element, Vault maps the value in this data element to the Literature Classification field of the Document record. |
| C.1.6.1.r | C.1.6.1.r.1 Documents Held by Sender (送信者が保有している資料) | For each qualifying document identified in the C.1.6 Additional Available Documents Held by Sender data element, Vault maps the value in this data element to the Attachment Description field of the Localized Case Document record. |
| C.4.r | C.4.r.1 Literature Reference(s) (引用文献) | For each qualifying document identified in the C.4.r Literature Reference(s) data element, Vault maps the value in this data element to the Reference Text field of the Localized Case Document record. |
| G.k | 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) | If the G.k section includes a J2.4.k License Category of New Drug data element, Vault considers the product a Company Product and maps the value to Local Product Code field of the Case Product Registration. If the section does not include a J2.4.k License Category of New Drug data element, Vault considers the product an External Product and maps the value to the Local MPID field on the Localized Case Product record. |
| H | 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) | The text from the Narrative Text field on the Japan Localized Case, to a limit of 100,000 characters. |