Create Workbench PMDA Postmarket Aggregate Reports

Safety Workbench provides Pharmaceuticals and Medical Devices Agency (PMDA) Postmarket report authoring and table generation capabilities. The Vault Safety PMDA Postmarket report adheres to the PMDA Guide to Electronic Reporting of Adverse Drug Reactions and Infectious Diseases.

The following table summarizes the Workbench PMDA Postmarket tabulations that Safety Workbench generates:

Tabulation	Masking Support?
J-NUPR Line Listing Form 7-2	No
J-PSR Cumulative Tabulation of Adverse Events Form 3	No
J-PSR Line Listing of Adverse Events Form 4	No
Case Series Report	No
Open Cases Report	No

Prerequisites

To generate Workbench PMDA aggregate reports:

• Your Admin must configure the PMDA Postmarket Workbench Report Set
• Your Admin must grant you permissions to view and prepare aggregate reports
• Depending on your business process, your Admin may:
  • Configure a Datasheet for each Study Product, Study, or Product with a list of expected adverse events in order to classify adverse events as Listed or Unlisted in Workbench PMDA reports
  • Configure custom Workbench PMDA Postmarket Workbench Report Set templates for your organization

Overview

To generate a Workbench PMDA aggregate report:

1. Create a Workbench Report Set to combine the desired PMDA Workbench Report Definitions into a single record.
2. Specify the required PMDA filters on the Workbench Report Set.
3. Generate then run the PMDA Workbench Reports from the Workbench Report Set.

To learn how Vault maps data to each Workbench PMDA report, see PMDA Table Generation Data Mapping.

Create a PMDA Postmarket Workbench Report Set

To create a PMDA Workbench Report Set:

1. Navigate to Workbench > Report Sets.
2. Select Create.
3. On the Create Workbench Report Set page, enter a name for the report.
4. Select Save or Save + Create to save the Workbench Report Set and create another.
5. In the Reports to Generate section, add a Workbench Report Definition to the Workbench Report Set for each PMDA report you want to include.

Result

Vault sets the lifecycle state of the Workbench Report Set to Draft.

PMDA Postmarket Filter Section Fields

You can specify the following fields for a PMDA Postmarket Workbench Report Set:

Field	Description
Date Filter	You can run reports with individual date filters, as well as in a report set. Select the date filter(s) from the following: J-PSR Previous Interval 1 (earliest) J-PSR Previous Interval 2 J-PSR Previous Interval 3 J-PSR Previous Interval 4 J-PSR Previous Interval 5 J-PSR Previous Interval 6 J-PSR Previous Interval 7 J-PSR Previous Interval 8 J-PSR Previous Interval 9 J-NUPR / J-PSR Current Interval
Case Completed	Select whether the Case is open or completed from the drop-down menu to filter the report. Consider the following: The Completed option includes Cases in the following states: Approved (approved_state__v) Closed (closed_state__v) Superseded (superseded_state__v) The Open option includes any Case in a state not defined as completed, including any custom lifecycle states. If you leave this field blank, the report filters for all Cases regardless of their state.
Aggregate Reporting Group	Select an Aggregate Reporting Group from the drop-down, or use the Advanced Search () icon to use filters and refine your search. Vault considers the following Cases eligible for inclusion in the generated reports: Cases with a Product in the Aggregate Reporting Group Cases with a Product Registration in the Aggregate Reporting Group

Generate Workbench PMDA Postmarket Tabulations

Review and verify the report settings. Once you have confirmed the report details are correct, use the Generate Aggregate Report Tabulations action to generate PMDA Postmarket report tables.

PMDA Postmarket Table Generation Data Mapping

Safety Workbench populates aggregate report tables using Cases within the reporting period specified on the PMDA Postmarket report, and the aggregate reporting group configured on the associated Aggregate Reporting Group. The following sections describe how Safety Workbench generates PMDA Postmarket tabulations:

• J-NUPR Line Listing Form 7-2
• J-PSR Cumulative Tabulation of Adverse Events Form 3
• J-PSR Line Listing of Adverse Events Form 4

J-NUPR Line Listing Form 7-2

Vault generates the J-NUPR Line Listing Form 7-2 by default for PMDA Postmarket aggregate reports.

Table Constraints

Vault filters Cases to include in the J-NUPR Line Listing Form 7-2 using the following constraints:

Case Not Suppressed

The Case Suppress Submission field must be set to No or blank (not suppressed).
case_version__v.suppress_submission__v ≠ Yes

Case Product or Product Registration in Aggregate Reporting Group

A Case must have a Product or Product Registration that is a member of the Aggregate Reporting Group.

• case_version__vr.case_product__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product__v
• case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v

Case Data in Interval Reporting Period

The date of a Case must be within the J-NUPR / J-PSR Current Interval Range. DATE ≥ nupr_jpsr_current_report_interval__v.data_period_start__v AND DATE ≤ nupr_jpsr_current_report_interval__v.data_period_end__v WHERE DATE selected is the Local Awareness Date.

If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed.

Case Lifecycle State

The latest Case version within the reporting period must be in a state specified in the Case Completed filter. case_version__v.state__v CONTAINS pmda_post_market__v.states_to_include__v

Consider the following:

• Cases in the following states are always omitted and cannot be selected in the States to Include field:
  • Nullified (nullified_state__v)
  • Voided (voided_state__v)
• The Completed option includes Cases in the following states: * Approved (approved_state__v) * Closed (closed_state__v) * Superseded (superseded_state__v)
  • The Open option includes any Case in a state not defined as completed, including any custom lifecycle states.
  • If you leave this field blank, the report filters for all Cases regardless of their state.

Localized Case

A Case must have a Japan localized version to be included.

case_version__v.reporter_country__v = Japan

Case Product in Drug Roles to Include

Only include Case Products in the listing where Drug Role is “Suspect” or “Interacting”.

Postmarket Cases

Only include Cases that are considered postmarket.

The case_product_registration__v.registration_type_cv__v E2B code is one of the following: (1, 2, 5, 6, 7)

Special Report Classification

Exclude Cases with a Special Report Classification of “Research Report” or “Safety Measure”.

case_version__v.special_report_classification__v IN (safety_measure_report__v, research_report__v)

Unexpected Adverse Events

Include only events that meet all of the following criteria:

• The event is non-serious (localized_case_adverse_event__v.seriousness__v = Blank)
• The event is Unexpected (localized_case_assessment__v.expected__v != yes)
• The event is related to the product in the report (Causality Established is set to Yes or Blank for at least one Assessment Result)
• The event is reportable (localized_case_adverse_event__v. special_adverse_event__v != "Non-reportable Event")

Table Mapping

Sorting: Rows are in order of Event (PT) alphabetically, then by Adverse Event Onset Date (earliest first). Events with a blank Onset Date are listed last.

Number	Name	Description
	Case # (番号)	The Case Number case_version__v.case_number__v
	Event (PT) (基本語)	The Localized MedDRA Preferred Term Event in Japanese (from the local MedDRA version)
	MedDRA Code (MedDRAコード)	The MedDRA Preferred Term Code
	Gender (性別)	The sex on the Case If the field is blank, "不明" (Unknown in Japanese) is displayed.
	Age (年齢)	The normalized Age (in years) on the Case If age is not populated on the case, the report will display Age Group. If Age Group is not populated, it will display "不明" (Unknown in Japanese).
	Onset Date (副作用等発現 年月日)	The Onset Date of the Case Adverse Event, as entered in the Date of Onset field on the Case Adverse Event in the format "YYYY年MM月DD日" If the field is blank, "不明" (Unknown in Japanese) is displayed.
	Outcome (転帰)	The Outcome of the Case Adverse Event The value selected in the Case Adverse Event Outcome field.
	Report Type (報告の 種類)	The Case Report Type The value selected in the Case Report Type field.
	Remarks (備考)	Up to three items are displayed in this column: The Product Name (case_product__v.product_registration__v.trade_name__v) or Product Registration (case_product_registration__v. product_registration__v) The Destination Case ID, if it exists, for the Product Registration (transmission__v.destination_case_id__v for the product_registration__v)

J-PSR Cumulative Tabulation of Adverse Events Form 3

The following image map shows how Vault generates the J-PSR Cumulative Tabulation of Adverse Events Form 3 table.

Table Constraints

Vault filters Cases to include in the J-PSR Cumulative Tabulation of Adverse Events Form 3 using the following constraints:

Case Not Suppressed

The Case Suppress Submission field must be set to No or blank (not suppressed).
case_version__v.suppress_submission__v ≠ Yes

Case Product or Product Registration in Aggregate Reporting Group

A Case must have a Product or Product Registration that is a member of the Aggregate Reporting Group.

• case_version__vr.case_product__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product__v
• case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v

Case Data in Interval Reporting Period

The Case date must fall within the defined aggregate report interval reporting periods.

earliest(aggregate_report_intervals__v) ≤ DATE ≤ aggregate_report_intervals__v.latest(interval_end_date__v)

Where DATE Local Awareness Date: Data Period Start Date ≤ localized_case__v.local_awareness_date__v ≤ Data Period End Date

Configuring Report Intervals

When defining reporting periods, Vault evaluates the interval records based on the following rules:

Required Current Interval: You must enter at least one interval in the J-NUPR / J-PSR Current Interval Range field. Vault always treats this entry as the latest (most recent) interval.

Optional Historical Intervals: If the report requires a broader data window, you can configure up to nine additional historical intervals using the Previous J-PSR Interval 1 through Previous J-PSR Interval 9 fields.

Sequential Entry: Interval dates must be entered sequentially based on the total number of periods being reported.

Example: If you are running a report across three total intervals, you must populate dates in Previous J-PSR Interval 1, Previous J-PSR Interval 2, and the J-NUPR / J-PSR Current Interval Range.

If there are multiple versions of the Case among all the reporting intervals, Vault lists only the most recent Case version.

Case Lifecycle State

The latest Case version within the reporting period must be in a state specified in the Case Completed filter. case_version__v.state__v CONTAINS pmda_post_market__v.states_to_include__v

Consider the following:

• Cases in the following states are always omitted and cannot be selected in the States to Include field:
  • Nullified (nullified_state__v)
  • Voided (voided_state__v)
• The Completed option includes Cases in the following states: * Approved (approved_state__v) * Closed (closed_state__v) * Superseded (superseded_state__v)
  • The Open option includes any Case in a state not defined as completed, including any custom lifecycle states.
  • If you leave this field blank, the report filters for all Cases regardless of their state.

Localized Case

A Case must have a Japan localized version to be included.

case_version__v.reporter_country__v = Japan

Case Product in Drug Roles to Include

Only include Case Products in the listing where Drug Role is “Suspect” or “Interacting”.

Postmarket Cases

Only include Cases that are considered postmarket.

The case_product_registration__v.registration_type_cv__v E2B code is one of the following: (1, 2, 5, 6, 7)

Special Report Classification

Exclude Cases with a Special Report Classification of “Research Report” or “Safety Measure”.

case_version__v.special_report_classification__v IN (safety_measure_report__v, research_report__v)

Blind Setting

For Study Cases, only unblinded data is included in the report.

If your Admin has configured your Vault to isolate blinded clinical trial information, the Blinding Type on the Japan Case Product Registration must be set to Unblinded, Open, or blank.

case_product_registration__v.blinding_type__v != Blinded

Serious, Related Adverse Events

All Adverse Events that are Serious and Related are included. In addition, events that meet all of the following criteria are included:

• The Localized Case Adverse Event is Serious (localized_case_adverse_event__v.seriousness__v = !Blank)
• The event is related to the Product in the report (Causality Established is set to Yes or Blank for at least one Assessment Result)
• The event is reportable (localized_case_adverse_event__v.special_adverse_event__v != "Non-reportable Event")

A Case must have a Product or Product Registration that is a member of the Aggregate Reporting Group:

• case_version__vr.case_product__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product__v
• case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v

Vault excludes Adverse Events with no Assessment or Assessment Result records.

Reporting Interval Assignments

Vault includes Cases within a reporting interval when the applicable Case date (Local Awareness Date) is on or between the Interval Start Date and Interval End Date on the Interval Dates filter.

For example, the PMDA allows three different methods for handling cases with multiple versions. The following example is the method where only the latest version is reported:

• Interval 1: January 1 – March 31
• Interval 2: April 1 – June 30

If a Case has two versions with different Local Awareness Dates:

• Version 1 falls into Interval 1
• Version 2 falls into Interval 2

Result: Only Version 2 will be included, and it will only appear in Interval 2. Version 1 is excluded so the case is not counted twice.

Cases that do not fall into any reporting intervals will be dropped.

Table Mapping

Sorting: Rows are in order of Event (SOC) alphabetically, then Event (PT) alphabetically. Each reporting interval appears in a separate column.

Number	Name	Description
	Event (SOC) (器官別大分類)	The Localized MedDRA System Organ Class (SOC) affected by the Adverse Event in Japanese (from the local MedDRA version)
	Event (PT) (基本語)	The Localized MedDRA Preferred Term Event in Japanese (from the local MedDRA version)
	The Number of Adverse Events Reported (副作用・感染症の症例報告を行った症例数)	The number of reported Adverse Events for that reporting interval. A report can include mulitple reporting intervals. The reporting interval dates are included in the column headers of the report.
	Unknown (不明 )	The number of reported Cases that do not fall within the dates of any reporting interval on the report. This column appears only when the report interval dates have been set up incorrectly.
	Total During Reexamination Period (再審査期間中の合計)	The total number of Cases for the reexamination period for each row on the report.
	Remarks (備考)	Up to two items are displayed in this column: The Product Name (case_product__v.product_registration__v.trade_name__v) or Product Registration (case_product_registration__v. product_registration__v) The Destination ID, if it exists (transmission__v.destination_case_id__v)

J-PSR Line Listing of Adverse Events Form 4

The following image map shows how Vault generates the J-PSR Line Listing of Adverse Events Form 4 table.

Table Constraints

Vault filters Cases to include in the J-PSR Cumulative Tabulation of Adverse Events Form 4 using the following constraints:

Case Not Suppressed

The Case Suppress Submission field must be set to No or blank (not suppressed).
case_version__v.suppress_submission__v ≠ Yes

Case Product or Product Registration in Aggregate Reporting Group

A Case must have a Product or Product Registration that is a member of the Aggregate Reporting Group.

• case_version__vr.case_product__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product__v
• case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v

Case Data in Interval Reporting Period

The Case date must fall within the defined aggregate report interval reporting periods.

earliest(aggregate_report_intervals__v) ≤ DATE ≤ aggregate_report_intervals__v.latest(interval_end_date__v)

Where DATE Local Awareness Date: Data Period Start Date ≤ localized_case__v.local_awareness_date__v ≤ Data Period End Date

Configuring Report Intervals

When defining reporting periods, Vault evaluates the interval records based on the following rules:

Required Current Interval: You must enter at least one interval in the J-NUPR / J-PSR Current Interval Range field. Vault always treats this entry as the latest (most recent) interval.

Optional Historical Intervals: If the report requires a broader data window, you can configure up to nine additional historical intervals using the Previous J-PSR Interval 1 through Previous J-PSR Interval 9 fields.

Sequential Entry: Interval dates must be entered sequentially based on the total number of periods being reported.

Example: If you are running a report across three total intervals, you must populate dates in Previous J-PSR Interval 1, Previous J-PSR Interval 2, and the J-NUPR / J-PSR Current Interval Range.

If there are multiple versions of the Case among all the reporting intervals, Vault lists only the most recent Case version.

Case Lifecycle State

The latest Case version within the reporting period must be in a state specified in the Case Completed filter. case_version__v.state__v CONTAINS pmda_post_market__v.states_to_include__v

Consider the following:

• Cases in the following states are always omitted and cannot be selected in the States to Include field:
  • Nullified (nullified_state__v)
  • Voided (voided_state__v)
• The Completed option includes Cases in the following states: * Approved (approved_state__v) * Closed (closed_state__v) * Superseded (superseded_state__v)
  • The Open option includes any Case in a state not defined as completed, including any custom lifecycle states.
  • If you leave this field blank, the report filters for all Cases regardless of their state.

Localized Case

A Case must have a Japan localized version to be included.

case_version__v.reporter_country__v = Japan

Case Product in Drug Roles to Include

Only include Case Products in the listing where Drug Role is “Suspect” or “Interacting”.

Postmarket Cases

Only include Cases that are considered postmarket.

The case_product_registration__v.registration_type_cv__v E2B code is one of the following: (1, 2, 5, 6, 7)

Special Report Classification

Exclude Cases with a Special Report Classification of “Research Report” or “Safety Measure”.

case_version__v.special_report_classification__v IN (safety_measure_report__v, research_report__v)

Blind Setting

For Study Cases, only unblinded data is included in the report.

If your Admin has configured your Vault to isolate blinded clinical trial information, the Blinding Type on the Japan Case Product Registration must be set to Unblinded, Open, or blank.

case_product_registration__v.blinding_type__v != Blinded

Serious, Related Adverse Events

All Adverse Events that are Serious and Related are included. In addition, events that meet all of the following criteria are included:

• The Localized Case Adverse Event is Serious (localized_case_adverse_event__v.seriousness__v = !Blank)
• The event is related to the Product in the report (Causality Established is set to Yes or Blank for at least one Assessment Result)
• The event is reportable (localized_case_adverse_event__v.special_adverse_event__v != "Non-reportable Event")

A Case must have a Product or Product Registration that is a member of the Aggregate Reporting Group:

• case_version__vr.case_product__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product__v
• case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v

Vault excludes Adverse Events with no Assessment or Assessment Result records.

Reporting Interval Assignments

Vault includes Cases within a reporting interval when the applicable Case date (Local Awareness Date) is on or between the Interval Start Date and Interval End Date on the Interval Dates filter.

For example, the PMDA allows three different methods for handling cases with multiple versions. The following example is the method where only the latest version is reported:

• Interval 1: January 1 – March 31
• Interval 2: April 1 – June 30

If a Case has two versions with different Local Awareness Dates:

• Version 1 falls into Interval 1
• Version 2 falls into Interval 2

Result: Only Version 2 will be included, and it will only appear in Interval 2. Version 1 is excluded so the case is not counted twice.

Cases that do not fall into any reporting intervals will be dropped.

Table Mapping

Sorting: Rows are in order of reporting interval (earliest first), Event (SOC) alphabetically, Event (PT) alphabetically, New Info Date (earliest first), and then Case Number. If the New Info Date is blank, Vault references the Case Receipt Date (earliest first).

Each Reporting Interval heading appears on a separate line. If an interval has no Event PTs, Vault adds the following note:「該当なし」(“N/A” in Japanese).

Number	Name	Description
	Reporting Cycle # (番号)	The name of the reporting interval on the Interval Dates record. aggregate_intervals__vr.name__v
	Event (SOC) (器官別大分類)	The Localized MedDRA System Organ Class (SOC) affected by the Adverse Event in Japanese (from the local MedDRA version).
	Event (PT) (基本語)	The Localized MedDRA Preferred Term Event in Japanese (from the local MedDRA version). An asterisk (*) is prepended to unexpected Adverse Events.
	Gender (性別)	The sex on the Case. If the field is blank, Vault populates "不明" (Unknown in Japanese).
	Age (年齢)	The normalized Age (in years) on the Case. If age is not populated on the Case, the report displays Age Group. If the field is blank, Vault populates "不明" (Unknown in Japanese).
	Onset Date (副作用等発現 年月日)	The Onset Date of the Case Adverse Event, as entered in the Date of Onset field on the Case Adverse Event in the format "YYYY年MM月DD日". If the field is blank, Vault populates "不明" (Unknown in Japanese).
	Outcome (転帰)	The Outcome of the Case Adverse Event. The value in the Case Adverse Event Outcome field. If the field is blank, Vault populates "不明" (Unknown in Japanese).
	Infection or Adverse Event (副作用・感染症の区分)	Vault references the Localized Case Adverse Event to populate this data. If the Special Adverse Event field is set to "Infection", Vault populates 感染症 (Infection in Japanese). Otherwise, Vault populates 副作用 (Adverse Event in Japanese).
	Report Type (報告の 種類)	The Case Report Type. The value in the Report Type field.
	PMDA ACK # (識別番号)	The Destination ID on the Transmission.

Case Series Report

The Case Series Report acts as a log file for all of the Cases included across all PMDA line listings and tabulations. Vault generates the Case Series Report in the following structure:

Reference Image Number	PMDA Report Field Name	Description
	Case Number	Vault maps the Case Number on the Case. case_number__v.id
	Case Name	Vault maps the Name on the Case. case_version__v.name__v
	Report Type	Vault maps the Report Type on the Case. case_version__v.report_type__v > localized_controlled_vocabulary__v.name__v
	Local Awareness Date	Vault maps the Local Awareness Date on the Case. localized_case__v > local_awareness_date__v
	Case Completed	Vault maps whether the Case is Open or Completed on the Case. If completed__v then 'Completed' else 'Open'
	Eligible for J-NUPR	Vault maps if the Case has a valid event for J-NUPR.
	Eligible for J-PSR	Vault maps if the Case has a valid event for J-PSR.

Open Cases Report

The Open Cases Report is an operational report intended to help you identify open Cases that may need to be closed before PMDA submission. It contains a log of all Cases that would be included in at least one PMDA tabulation were they in the Closed, Approved, or Superseded lifecycle state.

Vault generates the Open Cases Report in the following structure:

Reference Image Number	PMDA Report Field Name	Description
	Case Number	Vault maps the Case Number on the Case. case_number__v.id
	Case Name	Vault maps the Name on the Case. case_version__v.name__v
	Eligible for J-NUPR	Vault maps if the Case has a valid event for J-NUPR.
	Eligible for J-PSR	Vault maps if the Case has a valid event for J-PSR.
	Local Awareness Date	Vault maps the Local Awareness Date on the Case. localized_case__v > local_awareness_date__v
	Locked By Department	Vault maps the Department value of the Locked By user on the Case. case_version__v.locked_by_department__v.name__v
	Locked By User	Vault maps the Name value of the Locked By user on the Case. case_version__v.locked_by_user__v.name__v
	Report Type	Vault maps the Report Type on the Case. case_version__v.report_type__v > localized_controlled_vocabulary__v.name__v