# PMDA Case Field Reference Domestic _Cases_ and _Localized Cases_ support region-specific fields for data entry and validation when reporting to the PMDA. For general information on case processing for Japan, see Complete Intake and Process Cases for the PMDA. ## Details Section Fields {#pmda-details-fields} The following Japan-specific _Details_ section fields may be available. For information on other _Details_ section fields, see Localized Case Field Reference.
Field Description
Local Awareness Date

For domestic Localized Cases, Vault populates the New Info Date on the global Case. If the New Info Date changes on the global Case, Vault maps the change to this field.

For foreign Localized Cases, enter the date when the local affiliate became aware of the report.

Vault populates this value in the J2.2.1 data element of PMDA E2B(R3) reports.
Local Initial Receipt Date

Enter the date 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.

Vault populates this value in the C.1.4 data element on PMDA E2B(R3) reports. If blank, Vault populates the Initial Receipt Date on the global Case.
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.

Vault populates this value in the C.1.5 data element on PMDA E2B(R3) reports. If blank, Vault populates the New Info Date on the global Case.
Special Adverse Event

Specify whether any Localized Case Adverse Event has special characteristics that affect PMDA submission. Currently, Vault supports two (2) Special Adverse Event types:

  • 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

When the Generate Local Reporting Details action runs, the Special Adverse Event setting may impact the PMDA Reporting Category and Due Date.

For more information, see Adverse Events Section.
## Products Section Fields {#pmda-products-fields} The following Japan-specific _Products_ section fields may be available. For information on other _Products_ section fields, see Localized Case Field Reference.
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.
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.
### Localized Case Product Device Code Section Fields {#lcpdc-fields} The following Japan-specific _Localized Case Product Device Code_ section fields may be available. For information on other _Localized Case Product Device Code_ section fields, see Localized Case Field Reference.
Field Description
Local Term Enter a local term for local device reporting that corresponds to an IMDRF code.
Possible Patient Health Damage Select whether patient health damage is Suspected or Possible.
Expectedness Select whether the health damage or defects are Expected or Unexpected.
Onset Date Enter the onset date of health damage or defects. Use the calendar to select the date or enter the date manually.
## Case Product Registration Section Fields {#pmda-cpr-fields} The following _Case Product Registration_ fields may be available:
Field Description
Name The name of the Case Product Registration
Case A reference to the associated Case
Localized Case A reference to the associated Localized Case
Case Product A reference to the parent Case Product
Product A reference to the Product that contains the Japan Product Registration
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 Types are available by Registration Category:

Investigational

  • Approved (excluding investigational drugs)
  • Unapproved
  • Unapproved (excluding investigational drugs)
  • Under Partial Change Trial
  • Under Partial Change Trial (TIKEN)

Postmarketing

  • Not Applicable
  • Post Market Study
  • Under EPPV
  • Under Re-examination
  • Within 2 Years After Approval

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 This field is no longer used.
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.
Device/Product Generic Name Enter the generic name of the device or product to be reported to the PMDA.
JMDN Code When the generic name of the device or product is in the Japan Medical Device Nomenclature (JMDN), enter the associated JMDN code.
Device/Product Details Enter details about the device or product to be reported to the PMDA.
Device Classification 1 Select the Device Classification 1 of the device to be reported to the PMDA.
Device Classification 2 Select the Device Classification 2 of the device to be reported to the PMDA.
Device Classification 3 Select the Device Classification 3 of the device to be reported to the PMDA.
Regenerative Classification Select the Regenerative Classification of the device to be reported to the PMDA.
Device/Regenerative Usage Status Select the usage status of the device or product to be reported to the PMDA.
Device/Regenerative Usage Count Enter the usage count of the device or product to be reported to the PMDA.
Device/Regenerative Usage Period Enter the numeric value for the usage period of the device or product to be reported to the PMDA.
Device/Regenerative Usage Period (unit) Select the unit that applies to the usage period for the device or product to be reported to the PMDA.
Device/Product Collection Status Select whether the device or product is Collected, Uncollected, or if the status is Unknown.
Uncollected Status For uncollected devices and products, select a reason for the status.
Regenerative Conditional Approval Select whether conditional approval of the product is Applicable or Not Applicable.
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

Vault never populates the Blinded Reference, including for unblinded Case Products.

For more information, see Isolate Blinded Clinical Trial Information.
## Local Reporting Details Section Fields {#pmda-lrd-fields} Vault maps _Local Reporting Details_ record values to PMDA E2B(R3), PMDA MHLW Paper Forms, and PMDA postmarket medical device and regenerative medicine forms. The following _Local Reporting Details_ fields may be available:
Field Description
Case A reference to the associated Case
Localized Case A reference to the parent 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.
Registration Holder/Applicant Vault populates the Registration Holder/Applicant from the PMDA Product Registration related to the primary Case Product Registration for the Local Reporting Details record. When Products have Product Registrations for multiple Marketing Authorization Holders (MAHs), Vault generates Local Reporting Details and related records per MAH based on configured reporting rules.
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
  • Whether the adverse event relates to a device or regenerative medicine product
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.

Vault maps this value 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.

Vault maps this value 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 ICSR Transmission.

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.

Vault maps this value 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.
Device Case Expectedness Depending on whether the package insert lists the reported defect, select Expected or Unexpected.
Device Event Date Enter the date the reported defect occurred. Use the calendar to select the date or enter the date manually.
Contact Person Select a contact person for the device or regenerative medicine report to the PMDA.
Device Outcome Select the outcome of the device-related adverse event.
Device Outcome (other) Enter details about the outcome of the device-related adverse event.
Patient Health Effect Status Select a Patient Health Effect Status from the picklist.
Device Problem Status Select a Device Problem Status from the picklist.
Device Future Action Classification Select a classification for future action to be taken on the device.
Reference Number Enter the reference number for the device or regenerative medicine product.
Reference Number Year Enter the year the reference number was approved for the device or regenerative medicine product.
Previous Reference Number Enter the previous reference number for the device or regenerative medicine product.
Previous Reference Number Year Enter the year the previous reference number was approved for the device or regenerative medicine product.
## PMDA Reportable Products Section Fields {#pmda-reportable-prods-fields} The following _PMDA Reportable Products_ fields may be available:
Field Description
Case A reference to the associated Case
Localized Case A reference to the parent Localized Case
Case Product A reference to the 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 Fields {#pmda-comments-fields} The following _Case Comments_ fields may be available:
Field Description
Comments Label

Select a label to describe the type of comment. Your selection determines whether and how Vault exports this Case Comment to PMDA E2B(R3) reports. The following table shows each Comments Label and its corresponding PMDA E2B(R3) data element:

Comments Label E2B Element
Company Comments H.4
Receipt Date Comments J2.2.2
Comments on Completeness J2.7.2
Downgrade Reason J2.8.2

Retrospective analysis of infections

Vault generates this only when the Special Adverse Event is designated an Infection.

 J2.9
Future Actions J2.10
Other References J2.11

Report Overview

Vault generates this only when the Case has a Special Report Classification of Safety Measure Report or Research Report.

 J2.16

Vault includes additional Comments Labels. These values will support future PMDA reporting functionality.
Comments Text

Enter the comment.

When Comment Labels is 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 {#ae-section} The following Japan-specific _Adverse Event_ section fields may be available. For information on other _Adverse Event_ section fields, see Localized Case Field Reference.
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.
Localized Event (LLT) Vault populates the localized MedDRA LLT based on the Event (LLT) of the global Case Adverse Event. If the global Event (LLT) changes, Vault updates this field.
## Assessments Section Fields {#pmda-assessments-fields} The following Japan-specific _Assessment_ section fields may be available. For information on other _Assessment_ section fields, see Localized Case Field Reference.
Field Description
Due Date

Vault populates the due date for reporting the Case Adverse Event and Case Product Registration pair. If the Localized Case Assessment does not pass any reporting rules, this field is blank.

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

Vault calculates the number of days in which the report is due based on the applicable reporting rules for the Case Adverse Event and Case Product Registration pair.

For Localizations without the PMDA Due Dates Based on Localized Case Assessments feature enabled, Vault calculates due dates 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.
Expectedness Details

Following expectedness evaluations, Vault populates a comment with additional context for the evaluation. If the local expectedness has not been evaluated, Vault does not populate this field.

If you override the Vault-evaluated Expectedness on the Japan Localized Case Assessment, Vault populates Manually Selected in this field.
## Assessment Result Section Fields {#pmda-assessment-results-fields} The following Japan-specific _Localized Case Assessment Result_ section field may be available. For information on other _Localized Case Assessment Result_ section fields, see Localized Case Field Reference.
Field Description
Source Causality Comments Enter a summary of the causality assessment evaluation provided by the source in the local language.
## Documents Section Fields {#pmda-documents-fields} The following Japan-specific _Documents_ section fields may be available. For information on other _Documents_ section fields, see Localized Case Field Reference.
Field Description
Measure Classification Select a classification for the measure taken. Vault maps this value when generating standard postmarket forms 10 and 14 for reporting adverse events related to device and regenerative medicine products to the PMDA.
Measures Classification Details Enter details about the classification for the measure taken. Vault maps this value when generating standard postmarket forms 10 and 14 for reporting adverse events related to device and regenerative medicine products to the PMDA.