Learn about Vault Safety features that support the intake and processing of drug Cases for Japan and reporting 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 Intake and Case Processing for the PMDA
Vault Safety supports the intake and processing of postmarketing and investigational drug Cases that originate within and outside of Japan. This includes the following features:
- Text translation through automation or dual-entry fields
- Code terms using industry-standard dictionaries
- Capture of data points specific to PMDA reporting, including clinical trial requirements for foreign Cases
- Calculation of reportable product registrations, localized assessments, and due dates
- Generation of local reporting details, comments, and Submissions
For information on configuring all available capabilities on this page, see Prerequisites in PMDA Overview and Profile Setup.
Japan Case Intake
Vault Safety supports the intake of drug Cases reportable to Japan through the Inbox Item object. For general information on this topic, see Perform Local Language to English Intake.
You can complete intake for the following types of Cases:
- Domestic Cases: Cases reported from within Japan
- To create a Domestic Case for Japan, set the Inbox Item Localization field to Japanese (Japan).
- Localized Cases: Foreign cases reported from outside of Japan
- After the Global Case is approved, a Localized Case for Japan is automatically generated when the Case includes a Case Product Registration that is reportable to the PMDA.
For PMDA special report classifications, you can identify Safety Measure and Research Reports on Inbox Items.
Note: Although Vault Safety supports the PMDA E2B(R3) data elements in section J2, these fields are not available on the Inbox Item. You must enter the required data after promoting the Inbox Item to a Case.
Translating Inbox Items and Cases
When you save an Inbox Item with the Localization field set to Japanese (Japan), you can use the local intake fields to enter information in both Japanese and English. These dual-entry fields also appear on the Japan Domestic Case after promotion.
For foreign cases, enter details in Japanese on the Localized Case.
If your Admin has set up the Auto-Translation Framework, you can send all localized text fields for Inbox Items or Cases to Amazon Translate for translation into English.
Coding Inbox Item and Case Terms
Vault Safety supports Japanese coding of terms on Inbox Items and Cases using industry-standard dictionaries, as follows:
- Code medical terms for symptoms, diseases, indicators, and adverse events using the multilingual Medical Dictionary for Regulatory Activities (MedDRA). For more information, see Use the Multilingual MedDRA Browser in Code MedDRA Terms.
- This includes both current and J-Current terms, enabling coding different English terms that translate to the same Japanese characters
- The MedDRA language is set based on the Localization field
- Code external products using the Japan Drug Dictionary (JDD). For more information, see Code Japan Drug Dictionary Products.
- Code external products or add drug history to the Case using the WHODrug Dictionary. For more information, see Code WHODrug Products.
Note: JDrug and WHODrug codes do not currently code to each other in Vault Safety. Therefore, when coding external Products, both JDrug and WHODrug codes are required.
Case Processing
After you promote the Inbox Item to a Domestic Case or Vault generates a Localized Case, you can complete additional data entry, medical review, and Case validation.
Domestic and Localized Cases support region-specific fields for reporting to the PMDA. For general information on Domestic Cases, see Prepare a Domestic Case. For general information on Localized Cases, see Prepare a Localized Case.
The following diagram highlights the major Case processing steps that enable Vault Safety to determine reporting requirements for the PMDA.
The following sections highlight Japan-specific Case processing features and fields included in Vault Safety.
Details Section
The following table shows Japan-specific Details section fields. For information on other Details section fields, see Prepare a Localized Case.
| Field | Description |
|---|---|
| Local Awareness Date | For Domestic Localized Cases, this value is populated with the New Info Date on the Global Case. When the New Info Date is updated on the Global Case, the Local Awareness Date on the Domestic Localized Case is also updated. For Foreign Localized Cases, enter the date when the local affiliate became aware of the report. This populates the J2.2.1 Day 0 of Reporting Timeframe data element of PMDA E2B(R3) reports. |
| Local Initial Receipt Date | Enter the date when the Localized Case was received. Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. When populated on Localized Cases, this value is exported to the C.1.4 Date Report Was First Received from Source data element on PMDA E2B(R3) reports. If blank, the value in the Initial Receipt Date field on the Global Case is exported. |
| Local New Info Date | Enter the latest date when additional information was received about the Localized Case. Use the calendar to select the date or enter the date manually. Specify the year, month, and day at a minimum. When populated on Localized Cases, this value is exported to the C.1.5 Date of Most Recent Information for This Report data element on PMDA E2B(R3) reports. If blank, the value in the New Info Date field on the Global Case is exported. |
| Localized Parent Information | Reference to the Localized Case for the parent from the current (child) case. For a parent-child case, select the Localized Case for the parent. |
| Special Adverse Event | Specify whether any Localized Case Adverse Event has special characteristics that affect PMDA submission. Currently, two (2) Special Adverse Event types are supported:
For more information, see Adverse Events Section. |
Products Section
The following table shows Japan-specific Products section fields. For information on other Products section fields, see Prepare a Localized Case.
| Field | Description |
|---|---|
| Local MPID | Enter the region-specific Medicinal Product Identification (MPID) code on a Localized Case Product for an External Product. For Company Products, the Local Product Code field on Case Product Registrations should be used. This populates the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element of PMDA E2B(R3) reports. |
| JDrug | The Product code from the Japan Drug Dictionary. This field appears for External Products only. For information on coding with the Japan Drug Dictionary, see Code Japan Drug Dictionary Products. |
| Local Product Code | The Local Product Code from the Japan Product Registration if available. Otherwise, you can enter the region-specific Product Code. This populates the G.k.2.3.r.1 Substance / Specified Substance Name data element of PMDA E2B(R3) reports. |
Case Product Registration Section
The Case Product Registration section captures Japan Case Product Registrations. For both Domestic and Localized Cases, during Case Product Registration record creation, details are mapped from the PMDA Product Registration when available. See the sections below for information on when Vault generates records for Domestic Cases and Localized Cases.
Case Product Registration and Assessment records are not generated for Device or OTC-Device Case Products or Device Constituents of Combination Products.
Domestic Case Product Registration Generation
On Domestic Cases for Japan, when a Japan Product Registration is selected for the Case Product, Vault populates Case Product Registration records and the associated Assessment records. Case Product Registrations and Assessments are generated in the following scenarios:
- Upon Case Promotion if a Japan Product Registration exists on the Inbox Item
- When the Re-generate Domestic Case action is used
- When a Case Product with a PMDA Product Registration is added with a Drug Role of Suspect, Interacting, or Drug Not Administered
- When the Product Registration of an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered is changed from a blank or non-PMDA Product Registration to a PMDA Product Registration
- When the PMDA Product Registration of an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered is changed to a different PMDA Product Registration
- When the Evaluate Regulatory Conformance action is used
Vault deletes Case Product Registration and associated Assessment records when an existing Case Product with a Drug Role of Suspect, Interacting, or Drug Not Administered has the Product Registration changed from a PMDA Product Registration to either a non-PMDA Product Registration or is made blank.
Localized Case Product Registration Generation
Depending on your Admin’s setup, Vault may generate Case Product Registration records upon Localized Case creation. Case Product Registrations can also be added through the Retrieve Reportable Case Product Registrations action in the All Actions menu.
When populating reportable Case Product Registrations, Vault evaluates all reporting obligations in the following instances:
- Marketing Registrations (General Reporting)
- Marketing Registrations (Cross Reporting)
- Investigational Registrations (General Reporting)
- Investigational Registrations (Cross Reporting)
- A Product reportable to the PMDA includes the same Substance as a Suspect or Interacting Case Product on the Localized Case (see both Cross Reporting scenarios linked above)
Existing Case Product Registration records are considered not reportable and removed from the Domestic or Localized Case in the following instances:
- The Drug Role of the associated Case Product is no longer Suspect, Interacting, or Drug Not Administered.
- The associated Case Product or Study Product was deleted
Marketing Registrations (General Reporting)
The Japanese Registration Category is Marketing and the following details from the Localized Case Product match a Case Product Registration:
- Dose Form, Strength Number, and Strength Unit
If the above don’t all match, Vault matches on Dose Form alone. - The Japan Product Registration is set up as the default registration
If there are multiple matches, Vault selects the Japan Product Registration with a matching Dose Form and the earliest created date.
Marketing Registrations (Cross Reporting)
If Vault did not create a Marketing Case Product Registration for general reporting, then Vault generates the following Case Product Registrations for each Case Product for cross reporting:
- One (1) Case Product Registration from the Marketing Registrations for the Case Product using the same selection criteria as for Marketing Registrations (General Reporting).
- For the exact Substance-matched cross-reportable Products, a Case Product Registration for one (1) registration per exact matching cross-reportable Product using the same selection criteria as for Marketing Registrations (General Reporting).
- If there are no exact Substance-matched cross-reportable Products, then for each partial Substance-matched cross-reportable Product, Vault generates a Case Product Registration for one (1) registration per partial matching cross-reportable Product using the same selection criteria as for Marketing Registrations (General Reporting).
Investigational Registrations (General Reporting)
The Japanese Registration Category is Investigational.
If there are multiple matches, Vault adds them all to the Localized Case.
Investigational Registrations (Cross Reporting)
For Investigational Registrations registered to the PMDA, Vault generates a Case Product Registration for cross reporting if it is a Registration for a Product on the Case or a Registration for a cross-reportable Product with exact matching Substances.
PMDA Case Product Registration Fields
The following table outlines the fields available on Case Product Registration records.
| Field | Description | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | The name of the Case Product Registration | ||||||||||||||||||||||
| Case | A reference to the parent Case | ||||||||||||||||||||||
| Localized Case | A reference to the associated Localized Case | ||||||||||||||||||||||
| Case Product | A reference to the parent Case Product | ||||||||||||||||||||||
| Product | A reference to the Case Product | ||||||||||||||||||||||
| Rank | The Case Product rank | ||||||||||||||||||||||
| Product Registration | A reference to the Japan Product Registration | ||||||||||||||||||||||
| Registration Type | The Registration Type from the Japan Product Registration if available. Otherwise, you can select the product registration type. The following PMDA Registration Type options are available:
This populates the J2.4.k License Category of New Drug data element of PMDA E2B(R3) reports. |
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| Registration Country | The Registration Country from the Japan Product Registration | ||||||||||||||||||||||
| Registration Holder/Applicant | The Registration Holder from the Product Registration record. If this field is blank, the value is mapped from the Organization field of the Product Registration. Vault truncates values longer than 60 characters. | ||||||||||||||||||||||
| Registration Number | The Registration Number from the Japan Product Registration if available. Otherwise, you can enter the product authorization or application number for the country where the product is marketed. | ||||||||||||||||||||||
| Dose Form | The Dose Form from the Japan Product Registration if available. Otherwise, you can select an option from the dropdown list. | ||||||||||||||||||||||
| Local Product Code | The Local Product Code from the Japan Product Registration if available. Otherwise, you can enter the region-specific Product Code. This populates the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element of PMDA E2B(R3) reports. |
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| Clinical Compound Number | The Clinical Compound Number (CCN) from the Japan Product Registration if available. Otherwise, you can enter the CCN of the investigational drug. This populates the J2.12 Clinical Compound Number (CCN) data element of PMDA E2B(R3) reports. If the Product Reported (Override) and Local Product Code fields are blank, this populates the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element as well. |
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| Product (Reported) Override | This value is populated from the Product Registration record to be used for Study Cases with the following setup:
This supports the scenario when a Foreign Case Product has multiple investigational registrations for studies conducted in Japan with the same substance This populates the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element of PMDA E2B(R3) reports. |
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| OTC Drug Classification | The OTC Drug Classification from the Japan Product Registration if available. Otherwise, you can select an option from the picklist. This populates the J2.5.k Classification of OTC drugs data element of PMDA E2B(R3) reports. |
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| OTC Drug Channel | The OTC Drug Channel from the Japan Product Registration if available. Otherwise, you can select an OTC Drug Channel or Reason Omitted option from the available picklists. This populates the J2.6.k Obtaining channels for OTC drugs data element of PMDA E2B(R3) reports. |
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| PMDA Rank | Enter a number to assign the PMDA Rank. The rank of Case Product Registrations with PMDA Rank At least one Case Product Registration must be assigned PMDA Rank |
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| Due Date | Vault populates this field with the earliest Localized Case Assessment Due Date associated with this Case Product Registration when reporting rules are evaluated. For more information, see Evaluate Reporting Obligations for Localized Case Assessments. | ||||||||||||||||||||||
| Due in Days | Vault calculates this value for the Case Product Registration based on the most conservative Localized Case Assessment. | ||||||||||||||||||||||
| Local Expedited Criteria | Indicates if the Case Product Registration was evaluated as Local Expedited with the Local Expedited Criteria reporting rule. Once the Rule Engine sets the Local Expedited Criteria field on the Localized Case Assessment (LCA) record, Vault sets the Local Expedited Criteria field on the associated Case Product Registration (CPR) using the following logic:
When the Generate Local Reporting Details action runs, Vault uses this value to set the Local Expedited Criteria field on the Local Reporting Details record and its associated Submission, as described in One Last Time Reporting for Japan (PMDA) in Report to the PMDA. The Local Expedited Criteria on the Submission populates the C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? data element of PMDA E2B(R3) reports. |
Local Reporting Details Section
If your Admin has enabled the PMDA Local Reporting Details Generation and Submission Linking feature, you can select the Generate Local Reporting Details action in the All Actions menu on Japan Domestic and Localized Cases. For all Japan Case Product Registrations with values in the Due Date and Due in Days fields, Vault generates a Local Reporting Details record for each of the primary Postmarketing and Investigational Registration Types, if they exist on the Case.
The primary Case Product Registration is determined using the following priority order:
- The earliest Due Date for each Registration Type, for example, Postmarketing or Investigational.
- If there are multiple registrations for a Registration Type with the same Due Date, the highest Rank is evaluated.
- The evaluation depends on the Registration Type:
- Postmarketing: If there are multiple registrations with the same Rank, the earliest Created Date is evaluated.
- Investigational: If there are multiple registrations with the same Rank, the CPR linked to a Study Product or Product on the Case is evaluated. If there are still multiple, the earliest Created Date is evaluated.
In addition to generating Local Reporting Details records, the Generate Local Reporting Details action generates records as follows:
- PMDA Reportable Products records as described in PMDA Reportable Products Section.
- Case Comments records as described in Case Comments Section.
- Submission records as described in Submission Generation and Linking for PMDA Localized Cases.
Note: Vault considers Case Product Registrations without Due Date or Due in Days values to be not reportable.
Local Reporting Details Section Fields
The following table outlines the fields available on Local Reporting Details records.
PMDA Reportable Products Section
The PMDA Reportable Products section is generated through the Generate Local Reporting Details action and PMDA Reportable Products records are used to associate the Local Reporting Details record with the Reportable Products of the Case Product or Case Product Registration. In the PMDA Reportable Products section, Ranks are assigned by Registration Category and Drug Role as follows:
- For Marketing registrations, Vault assigns Rank 1 to the primary Case Product Registration from the Local Reporting Details section. Vault then ranks Other Postmarketing registrations in the following order based on Drug Role:
- Suspect
- Interacting
- Other
- For Investigational registrations, Vault assigns Rank 1 to the Case Product Registration with a Drug Role of Suspect. Vault then ranks in order based on Drug Role, including:
- Suspect
- Interacting
- Other
- For Investigational registrations with the same Drug Role, Vault assigns Rank based on the Rank in the Case Product Registration section.
Note: If Local Reporting Details are system-generated, Vault assigns a Rank based on the Rank in the Case Product Registration section.
PMDA Reportable Products Section Fields
The following table outlines the fields available on PMDA Reportable Products records.
| Field | Description |
|---|---|
| Case | A reference to the parent Case |
| Localized Case | A reference to the associated Localized Case |
| Case Product | A reference to the parent Case Product |
| Case Product Registration | A reference to the Case Product Registration. |
| Drug Role | A reference to the Case Product Registration drug role. |
| Rank | Rank indicates the order in which Products appear in the G.k section of PMDA E2B(R3) reports. |
Case Comments Section
The Case Comments section is generated through the Generate Local Reporting Details action and Localized Case Comment records are linked to their associated Local Reporting Details record. Use the Case Comments section to add PMDA (Japan) region-specific comments.
Case Comments Section Fields
The following table outlines the fields available on Case Comments records.
| Field | Description | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comments Label | Select a label to describe the type of comment. The option that you select in this field determines how this Case Comment is exported in PMDA E2B(R3) reports. The following table outlines the E2B data elements corresponding to each option:
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| Comments Text | Enter the comment. When Comment Label is set to Report Overview, the maximum number of characters is 500. |
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| Local Reporting Details | A reference to the Local Reporting Details record. Select or search for the Local Reporting Details from the Localized Case. If this field is empty, the Case Comments will be used in all LRDs where the LRDs do not have Case Comments with same Comments Label and an LRD specified. |
Adverse Events Section
Each Case Adverse Event from the Global Case is snapshotted to create Localized Case Adverse Events. For more information, see Adverse Events Section in Prepare a Localized Case. The following table shows the Japan-specific Localized Case Adverse Event section field.
Assessments Section
Vault supports generating Localized Case Assessment records for each Case Product Registration. To use this option, your Admin must turn on Localized Assessments for Case Product Registrations under Assessment Generation for the related Localization record.
When turned on, for Suspect, Interacting, or Drug Not Administered Case Products, for each Case Product Registration Vault generates Localized Case Assessment records and calculates Expectedness. For example, if the Localization record for Japanese (Japan) is set to generate Localized Assessments for Case Product Registrations, Localized Case Assessments are automatically generated by Vault for each Case Product Registration.
With this feature, Localized Case Assessments are also generated when Adverse Events are added to Cases. When existing Adverse Events are recoded to a different MedDRA LLT, Localized Case Assessments are updated and Expectedness is reevaluated. If your Admin has enabled Datasheet Expectedness by Age and Sex, Expectedness is also re-evaluated if you change either the sex or any age-related field (including Date of Birth, Age at Onset, or Age Group) of the Case Patient.
For general information on Localized Case Assessments, see Assessments Section in Prepare a Localized Case.
Assessment records are not generated for Device or OTC-Device Case Products or Device Constituents of Combination Products.
Evaluate Reporting Obligations for Localized Case Assessments
Use the Evaluate Reporting Obligations action to evaluate general and cross reporting obligations for Localized Case Assessments. Before evaluating reporting obligations, ensure you have retrieved all the reportable Case Product Registrations. For more information, see Case Product Registration Section.
If your Admin has not configured your Vault to generate Localized Assessments for Case Product Registrations, see Evaluate Reporting Obligations for Localized Transmissions in Prepare a Localized Case.
After running the Evaluate Reporting Obligations action, Due Dates and Due in Days calculations are populated on each Localized Case Assessment record. Details are populated as follows:
- Due in Days is calculated based on the applicable reporting rules.
- Due Date calculations depend on your Admin’s setting in the Localization record’s Localized Due Date Calculation field. The following options may be configured:
- If set to Localized Case - Local Awareness Date, the Due Date is based on the Local Awareness Date and the Due in Days evaluation. If the Local Awareness Date is blank, Vault uses the New Info Date, if available, or the Receipt Date.
- If set to Global Case - New Info Date, the Due Date is based on the New Info Date and the Due in Days evaluation. If the New Info Date is blank, Vault uses the Receipt Date.
When you run the Evaluate Reporting Obligations action, Transmissions are not generated. Transmission are generated when the Generate Local Reporting Details action is run and Local Reporting Details records are generated.
Assessments Section Fields
Some of the Assessments fields in the table below appear only when your Vault is configured to generate Localized Case Assessments for Case Product Registrations.
| Field | Description |
|---|---|
| Due Date | The Due Date used for reporting the Adverse Event and Case Product Registration pair. This field is populated only for Japan Localized Cases if your Admin has configured your Vault to generate Localized Case Assessments and Due Dates for each Case Product Registration. How Vault calculates the Due Date also depends on your Admin's configuration. For more information, see Evaluate Reporting Obligations for Localized Case Assessments. If the Localized Case Assessment does not pass any reporting rules, this field is left blank. For Localizations with the Assessment Generation field not set to Localized Case Assessment for Case Product Registration, the Due Date is calculated at the Transmission level instead. |
| Due in Days | The number of days in which the report is due. See the Due Date field description above for details on the required configuration for the Due in Days field. The Due in Days value is calculated based on the applicable reporting rules for the Adverse Event and Case Product Registration pair. For Localizations with the Assessment Generation field not set to Localized Case Assessment for Case Product Registration, the Due Date is calculated at the Transmission level instead. |
| Case Product | The Suspect, Interacting, or Drug Not Administered Case Product. For Cases reportable to the PMDA, Vault downloads all associated Products with registrations for Japan. In addition, when the Retrieve Reportable Case Product Registrations action is run, Vault downloads all Products that are reportable to Japan and have the same Substance as the Suspect, Interacting, or Drug Not Administered Case Product. |
| Local Expedited Criteria |
When the Evaluate Reporting Obligations action runs, the Rule Engine sets this field according to the Local Expedited Criteria for PMDA Localized Cases reporting rule parameter logic. Vault uses this Localized Case Assessment Local Expedited Criteria field to set the Local Expedited Criteria field of the associated Case Product Registration, Local Reporting Details, and Submission as described in One Last Time Reporting for Japan (PMDA) in Report to the PMDA. |
Expectedness
On Domestic Cases for Japan, Expectedness records are not generated for Case Products with registrations that are reportable to the PMDA. Instead, Expectedness evaluations appear on Localized Case Assessment 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 more information on how Vault evaluates the Most Reportable Case Product and Case Assessment, see Configure Reporting Rules Product Selection .
When the Localized Case Assessment Expectedness or Expected (status) value is overridden, the update is synced to the Global Case for Domestic Cases, but not for Localized Cases.
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