PMDA Case Field Reference

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.

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.

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.

The latest date 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

For more information, see Isolate Blinded Clinical Trial Information.

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.

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.

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.

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.

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.

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.

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:

Enter the comment.

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

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.

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.

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.

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.

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.

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.