Complete Intake and Process Cases for the PMDA

Learn about Vault Safety features that support the intake and processing of drug cases for Japan and reporting to the PMDA.

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:

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 Inbox Items. 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.

Vault also supports importing PMDA E2B(R3) files to create Inbox Items for Japan Domestic Cases, including merging to an In-flight Case and promoting to a Follow-up Case through the Inbox to Case Compare page. For more information, see PMDA E2B(R3) Case Import.

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.

Code 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.

Cross-Referencing JDrug and WHO Drug Codes

Vault also supports cross-referencing JDrug and WHODrug codes during case processing using the WHODrug Cross Reference Tool (CRT) Japan. This eliminates manual code entry in the following instances:

  • Adding the applicable WHODrug code when processing a Japan domestic Case with an External Product coded using a JDrug code.
  • Adding the applicable JDrug code when processing a Japan foreign Localized Case with an External Product coded using a WHODrug code.

For information on configuring this feature, see Enable JDrug and WHODrug Cross Reference Tool. For information on using this feature, see Code Japan Drug Dictionary Products and Code WHODrug Products.

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.

Key Steps for PMDA Case Processing

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:

  • Infection: Indicates that at least one (1) Adverse Event is considered an Infection-related event
  • Non-reportable Event: Indicates that at least one (1) Adverse Event is not reportable to the PMDA

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

For External Products, enter the region-specific Medicinal Product Identification (MPID) on Localized Case Product records. For Company Products, the Local Product Code field on Case Product Registrations should be used.

During PMDA E2B(R3) generation, Vault maps this value to the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element. If the Japan Product Code Type is set to J-Drug Code, Vault also maps the first seven (7) digits of the Local MPID to the G.k.2.3.r.1 Substance / Specified Substance Name data element.
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.
External Product Coding Status

On domestic Cases for Japan, this field indicates the status and source of WHODrug codes on External Products. On Localized Cases for Japan, this field indicates the status and source of JDrug codes on External Products.

This field is available in Vaults configured with the JDrug and WHODrug Cross Reference Tool. To learn more, see Code Japan Drug Dictionary Products and Code WHODrug Products.
Japan Product Code Type

For Company Products, Vault populates the Japan Product Code Type from the Japan Product Registration if available. Otherwise, select an option from the picklist.

See Local Product Code and Local MPID for information on PMDA E2B(R3) generation when you select J-Drug Code in this field.
Blinding Type

Identifies whether a Localized Case Product on a Clinical Trial Study Case is blinded.

Vault sets this to one (1) of the following:

  • Blinded
  • Unblinded
  • Open
  • blank (for example, non-Study or External Products)

For more information, see Isolate Blinded Clinical Trial Information.
Blinded Reference

For Localized Case Product records on unblinded Clinical Trial Study Cases, links to the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

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. If your Admin has enabled Isolate Blinded Clinical Trial Information in your Vault, Vault deletes Case Product Registrations in this scenario only when the Blinding Type is not Blinded.

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.

For blinded Study Products, Vault generates Case Product Registration records using the following priority:

  • The primary blinded investigational Product identified on the Study Product Placeholder record
  • The earliest created Study Product with a Study Product Role of Investigational that is associated with the Study Product Placeholder record
  • The earliest created Study Arm Product with an associated Study Product that has a Study Product Role of Investigational

When populating reportable Case Product Registrations, Vault evaluates all reporting obligations in the following instances:

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:

PMDA Registration Type Registration Category (INV/ PMK)
Approved (excluding investigational drugs) INV
Not Applicable PMK
Post Market Study PMK
Unapproved INV
Unapproved (excluding investigational drugs) INV
Under EPPV PMK
Under Partial Change Trial INV
Under Partial Change Trial (TIKEN) INV
Under Re-examination PMK
Within 2 Years After Approval PMK

This populates the J2.4.k License Category of New Drug data element of PMDA E2B(R3) reports.
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

For Company Products, Vault populates the Local Product Code from the Japan Product Registration if available. Otherwise, you can enter the region-specific Product Code.

During PMDA E2B(R3) generation, Vault maps this value to the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element according to the logic described in PMDA E2B(R3) Generation Data Mapping.

In addition, if the Japan Product Code Type is set to J-Drug Code, Vault also maps the first seven (7) digits of the Local Product Code to the G.k.2.3.r.1 Substance / Specified Substance Name data element. Local Product Code mapping occurs regardless of values on the Japan Localized Case Product Substance record. For more information, see the G.k.2.3.r section of PMDA E2B(R3) Generation Data Mapping.
Japan Product Code Type

For Company Products, Vault populates the Japan Product Code Type from the Japan Product Registration if available. Otherwise, select an option from the picklist.

See Local Product Code for information on PMDA E2B(R3) generation when you select J-Drug Code in this field.
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.
Product (Reported) Override

This value is populated from the Product Registration record to be used for Study Cases with the following setup:

  • The Case Product is registered to Japan in multiple Studies.
  • The Case Reporter Country is not set to Japan.

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.
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.
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.
PMDA Rank

Enter a number to assign the PMDA Rank. The rank of 1 identifies the primary product for PMDA E2B(R3) reports.

Case Product Registrations with PMDA Rank 1 will be used when Registration Type reporting rule parameter is evaluated on the Case.

At least one Case Product Registration must be assigned PMDA Rank 1 to export an E2B file with PMDA mappings.
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:

  • If at least one LCA record has the Local Expedited Criteria field set to Yes, then Vault sets the Local Expedited Criteria field on the CPR record to Yes.
  • If any of the LCA records has the Local Expedited Criteria field set to No, then Vault sets the Local Expedited Criteria field on the CPR record to No.
  • If none of the above are true, Vault leaves the Local Expedited Criteria field on the CPR record blank.

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.
Blinding Type

Identifies whether a Case Product Registration on a Clinical Trial Study Case is blinded.

Vault sets this to one (1) of the following:

  • Blinded
  • Unblinded
  • Open
  • blank (for example, non-Study or External Products)

For more information, see Isolate Blinded Clinical Trial Information.
Blinded Reference

For Case Product Registration records on unblinded Clinical Trial Study Cases, links to the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

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:

  1. The earliest Due Date for each Registration Type, for example, Postmarketing or Investigational.
  2. If there are multiple registrations for a Registration Type with the same Due Date, the highest Rank is evaluated.
  3. The evaluation depends on the Registration Type:
    1. Postmarketing: If there are multiple registrations with the same Rank, the earliest Created Date is evaluated.
    2. 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:

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.

Field Description
Case A reference to the parent Case
Localized Case A reference to the associated Localized Case
Primary Case Product Select or search for the primary Case Product.
Primary Case Product Registration Select or search for the primary Case Product Registration.
PMDA Reporting Category

The reporting category that determines the reporting requirements based on Case and Adverse Event attributes under the PMDA guidelines. The PMDA Reporting Category indicates:

  • If the Case is domestic or foreign.
  • If the Case report type is Infection, Adverse Event, Research, or Safety Measure Report.

For Domestic and Localized Cases with the Localization set to Japan, Vault assigns the Reporting Category when the Local Reporting Details record is created or updated through the Generate Local Reporting Details action, based on the following attributes:

  • Whether the primary Case Product Registration of the Local Reporting Details is Postmarket or Investigational
  • Whether the primary Reporter Country is Japan
  • Whether the Case has a Special Report Classification, either Research Report or Safety Measure
  • Whether the Localized Case has a Special Adverse Event designated as Infection

This value is mapped to the J2.1a PMDA Reporting Category data element of PMDA E2B(R3) reports.
System Generated LRD Category Vault populates this field with "Investigational" or "Marketing".
Completeness

Select the option that best describes the completeness of the data collection at the time of the PMDA Report.

This value is mapped to the J2.7.1 Completion flag data element of PMDA E2B(R3) reports.
Immediate Report Type

Select System (E2B) to classify this report as an Immediate Report in PMDA reporting. When System (E2B) is selected, this field corresponds to code 1 in the PMDA J2.3 E2B data element.

This value is mapped to the J2.3 Flag for Immediate Report data element of PMDA E2B(R3) reports.
Destination Case ID

The value of the Destination Case ID field on the associated Transmission (Submission or Distribution) record.

If this field is blank, when a Transmission receives a positive ACK from the PMDA and the Destination Case ID is populated on the Transmission, Vault populates this field.

This value is mapped to the J2.1b PMDA Identification Number data element of PMDA E2B(R3) reports.
Report UID

This identifier is generated using the following logic:

case_number__v.name__v + suffix

The suffix is a two-letter sequence that increments by one letter from the last suffix of the existing Local Reporting Details record. The sequence starts with 'AA' and increments by one letter for each subsequent record (for example, AA, AB, AC, AD, and so on). Any unused suffixes in the sequence are used first.

TIKEN

Select the checkbox to prepend TIKEN to the G.k.11 Additional Information on Drug (free text) data element of PMDA E2B(R3) reports for the primary Case Product Registration.

If Local Reporting Details are generated by Vault or through the Generate Local Reporting Details action, this checkbox is automatically selected for the Marketing record if all of the Investigational Case Product Registrations for the same Product have the PMDA Registration Type field set to Under Partial Change Trial (TIKEN).

This checkbox is available for the PMDA-specific scenario where a foreign Case includes both postmarketing and investigational registrations for the same substance where the Registration Type is Under Partial Change Trial and the partial change is one of the following:

  • Route of Administration
  • Strength
  • Efficacy
  • A new, changed, or deleted Indication

In this scenario, when the PMDA requires only a postmarketing Transmission, Vault populates TIKEN to indicate that the investigational report was not generated.

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.

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:

Comments Label E2B Element
Company Comments (sender_comments__v) H.4
Receipt Date Comments (receipt_date_comments__v) J2.2.2
Comments on Completeness (comments_on_completeness__v) J2.7.2
Downgrade Reason (downgrade_reason__v) J2.8.2

Retrospective analysis of infections (retrospective_analysis_of_infections__v)

This is generated only when the Special Adverse Event is designated as an Infection.

 J2.9
Future Actions (future_actions__v) J2.10
Other References (other_references__v) J2.11

Report Overview (report_overview__v)

This is generated only when the Case has a Special Report Classification of Safety Measure Report or Research Report.

 J2.16
Comments Text

Enter the comment.

When Comment Label is set to Report Overview, the maximum number of characters is 500.
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.

Field Description
Special Adverse Event

Specifies if the Adverse Event has special characteristics that affect PMDA submission. Currently, two (2) Special Adverse Event types are supported:

  • Infection: Indicates that this Adverse Event is considered an Infection-related event. Infection-related events are included in E2B reports.
  • Non-reportable Event: Indicates that this Adverse Event is not reportable to the PMDA. Non-reportable events are excluded from any E2B reports associated with the Localized Case.

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, Vault generates Localized Case Assessment records and calculates Expectedness for each Case Product Registration.

With this feature, Vault generates Localized Case Assessments when you add Adverse Events to Cases. When you recode existing Adverse Events to a different MedDRA LLT, Vault updates Localized Case Assessments and reevaluates Expectedness. If your Admin has enabled Datasheet Expectedness by Age and Sex, Vault also re-evaluates Expectedness if you change 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

Before evaluating general and cross 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.

You can evaluate reporting obligations for Localized Case Assessments in the following ways:

  • On a Japan Domestic Case, go to the All Actions menu and select Calculate Due Dates on LCA.
  • On a Japan Localized Case, go to the All Actions menu and select Evaluate Reporting Obligations.

After running the applicable action to evaluate reporting obligations on the Localized Case, Vault populates the Due Date and Due in Days fields on each Localized Case Assessment as follows:

  • Due in Days: 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.

In addition, Vault rolls up the Due Date and Due in Days values to the related Case Product Registration as described in the PMDA Case Product Registration Fields.

Vault does not generate Transmissions through these actions.

Assessments Section Fields

Some of the Assessments fields in the table below appear only when your Admin has configured your Vault to generate Localized Case Assessments for Case Product Registrations.

Field Description
Due Date

The Due Date for reporting the Adverse Event and Case Product Registration pair. Vault populates this field only for Japanese Localized Cases. See Evaluate Reporting Obligations for Localized Case Assessments for details on Due Date calculation.

This field is blank if the Localized Case Assessment does not pass any reporting rules.

For Localizations without the PMDA Due Dates Based on Localized Case Assessments feature enabled, Vault calculates Due Dates at the Transmission level instead.
Due in Days

The number of days in which the report is due.

Vault calculates the Due in Days value based on the applicable reporting rules for the Adverse Event and Case Product Registration pair.

For Localizations without the PMDA Due Dates Based on Localized Case Assessments feature enabled, Vault calculates Due in Days 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 you run the Retrieve Reportable Case Product Registrations action, 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 you run the Evaluate Reporting Obligations action, 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 Justification If your Admin has configured the Japan Localization record to generate Localized Assessments for Case Product Registrations, Vault populates the value from the Expectedness Justification field for the adverse event on the Datasheet. You can enter or edit the value in this field, using up to 1,000 characters.
Blinding Type

Identifies whether a Case Assessment on a Clinical Trial Study Case is blinded.

Vault sets this to one (1) of the following:

  • Blinded
  • Unblinded
  • Open
  • blank (for example, non-Study or External Products)

For more information, see Isolate Blinded Clinical Trial Information.
Blinded Reference

For Case Assessment records on unblinded Clinical Trial Study Cases, links to the associated blinded record.

For more information, see Isolate Blinded Clinical Trial Information.

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.

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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Learn how to process Special Report Classification Cases.