Create PMDA Post-Market Aggregate Reports

Learn how to set up PMDA Post-Market aggregate reports and generate PMDA Post-Market report tables.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About PMDA Post-Market Reports

Vault Safety provides Pharmaceuticals and Medical Devices Agency (PMDA) Post-Market report authoring and table generation capabilities. The Vault Safety PMDA Post-Market report adheres to the PMDA Guide to Electronic Reporting of Adverse Drug Reactions and Infectious Diseases. In addition, for Japan Post-Market Serious (J-PSR) reports, Vault tracks reporting interval dates and combines data from new and previous reporting intervals to cover up to several years of information.

The following table summarizes the PMDA Post-Market tabulations that Vault Safety generates:

Tabulation	Generated by Default?	Masking Support?
NUPR Line Listing Form 7-2	Yes	No
J-PSR Cumulative Tabulation of Adverse Events Form 3	No	No
J-PSR Line Listing of Adverse Events Form 4	No	No

Note: Your Admin can configure custom PMDA Post-Market report templates for your organization.

Prerequisites

Consider the following prerequisites before you generate PMDA Post-Market report tables:

You must be assigned permissions to view and prepare aggregate reports. Typically, these permissions are reserved for the Aggregate Report Writer, Safety Writer, and Head of Safety roles.
Your Admin must have enabled the Japan Periodic Reporting - Post-Market Non-Serious (NUPR) and Japan Periodic Reporting: Post-Market Serious (J-PSR) features.
Your Admin must have configured the Reporting Family with the Products, Studies, Product Registrations, and Substances to include in the report.
To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must have enabled the Criteria Page for aggregate reports.

Create a PMDA Post-Market Aggregate Report

Create a PMDA Post-Market aggregate report and specify the report settings.

Add a PMDA Post-Market Report

Follow these steps to create a PMDA Post-Market report.

In the Vault primary navigation bar, select Aggregate Reports > PMDA Post-Market, and then select Create.
Complete the fields on the Create PMDA Post-Market page.
Save the page.

Result

The PMDA Post-Market record enters the Pending state. The system assigns a task to applicable users to review the report details and generates an Interval Dates section.

PMDA Post-Market Fields

You can specify the following fields for a PMDA Post-Market aggregate report:

Field	Description
Product Family (Required)	Select the Reporting Family configured for aggregate reporting. Note: The Reporting Family object type should be Product Family. To learn more, see Configure Aggregate Reporting Families.
Organization	This field is automatically populated with the Organization on the selected Reporting Family.
Data Period Start (Required)	Enter the start date for the reporting period. Vault uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Cases By setting is within the reporting period. Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date. Vault adds this date to the Interval Start Date field of the related or current Interval Dates record. To learn more, see How Aggregate Reports Filter by Data Period.
Data Period End (Required)	Enter the end date for the reporting period. Vault adds this date to the Interval End Date field of the related or current Interval Dates record. To learn more, see How Aggregate Reports Filter by Data Period.
Previous J-PSR Report	When generating J-PSR tabulations as part of the PMDA Post-Market report, you can select a previously generated J-PSR report for that Product Family if a prior reporting interval exists. Vault copies Interval Date records from the selected report into the current report. You can view the selected report through the link in the Previous Aggregate Report field of the related Interval Dates record. If you change the Previous J-PSR Report value, Vault updates the Interval Date records based on the new selection. To learn more, see How Aggregate Reports Filter by Data Period.
Filter Case By	To customize how Vault filter Cases within the specified date range, select an option: Case Receipt Date / New Info Date (Default): The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields. Case Approval Date: The date when the Case moved into the Approved state. If the Case was revised for a non-significant follow-up, the most recent Approval date is used. If this field is not specified, the Case Receipt Date/New Info Date are used by default. Depending on when your Vault was originally deployed, an Admin may need to add this field to appear on the layout.
Include Criteria Page on Documents	Select the checkbox to add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report. When selected, the criteria page summarizes the following: Report Parameters (including, the Document Name and Organization) Filter Parameters (for example, the Product Family, report period start and end date, and States to Include) Output Parameters (for example, Indicate Unexpected Terms and any additional fields displayed) Legend (for example, an asterisk (*) indicates an Unexpected Event) The criteria page is in English on Japanese reports.
States to Include (Required)	Select the states that Cases must be in to be included in the report. By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Although Superseded is not listed as an option, it is included within the Closed state. Only system-provided states in the Case Processing lifecycle are supported. Note: If the latest Case version within the aggregate reporting period is in the Nullified or Voided state or in a lifecycle state assigned to the Deleted state type, the Case is excluded from the aggregate report.
Documents to Generate	You can select which documents to generate. The following options are available: NUPR Line Listing Form 7-2 J-PSR Cumulative Tabulation of Adverse Events Form 3 J-PSR Line Listing of Adverse Events Form 4

Interval Dates

When you create a PMDA Post-Market report, Vault generates an Interval Dates section and populates an Interval Date record for the current report, showing the selected start and end dates for the reporting interval. If you populate the Previous J-PSR Report field when creating the report, Vault also copies all of the Interval Date records from the selected report into the current report. This supports tracking reporting cycles, which Vault uses to generate reports that combine new and previous reporting intervals to cover several years of data, per PMDA regulations.

Interval Date Fields

Field	Description
Name	Vault generates a name for the Interval Date record.
Interval Start Date	Vault maps the value entered in the Date Period Start field when creating the report. If the Date Period Start value is updated, Vault updates this field with the new value.
Interval End Date	Vault maps the value entered in the Date Period End field when creating the report. If the Date Period End value is updated, Vault updates this field with the new value.
Current Interval	Vault populates "Yes" for the latest reporting interval and "No" for previous reporting intervals. When a new PMDA Post-Market report is created for a Product Family, Vault updates this value to "No" on the previous reporting interval for the Product Family.
Current Aggregate Report	For each Interval Date record, Vault populates a link to the current aggregate report for that Product Family's reporting cycle. Vault updates this value on all related records when a new PMDA Post-Market report is created for the Product Family.
Previous Aggregate Report	For each Interval Date record, Vault populates a link to the aggregate report used to define the date intervals. This field is blank for the current interval.

Generate PMDA Post-Market 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 Post-Market report tables.

PMDA Post-Market Table Generation Data Mapping

Vault Safety populates aggregate report tables using Cases within the reporting period specified on the PMDA Post-Market report, and the reporting family members configured on the associated Reporting Family.

The following sections describe how Vault Safety generates PMDA Post-Market tabulations:

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

NUPR Line Listing Form 7-2

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

Table Constraints

Vault filters Cases to include in the 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 in Reporting Family

A Case Product must be a member of the Reporting Family.

case_version__vr.case_product__v.product__v IN aggregate_report_family__vr.aggregate_report_family_join__vr.products__v

Case Data in Interval Reporting Period

The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≤ pmda_post_market__v.data_period_end__v

where DATE depends on the option selected in the PMDA Post-Market Filter Cases By (pmda_post_market__v.filter_cases_by__v) field:

When Approval Date: case_version__v.approval_date__v
When blank or Receipt Date / New Info Date (Default):
- If the Case New Info Date (new_info_date__v) is blank, the Receipt Date is used: case_version__v.receipt_date__v
- Otherwise, the New Info Date is used: case_version__v.new_info_date__v

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 in Aggregate States to Include

The latest Case version within the reporting period must be in a state specified in the States to Include field on the PMDA Post-Market.

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)
- If the Case is in a Lifecycle State assigned a State Type of “Deleted”, the Case is omitted.
- When evaluating the States to Include field, Vault evaluates Cases in the Superseded (superseded_state__v) state as Closed (closed_state__v).

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”.

Post-Market Cases

Only include Cases that are considered post-market.

The case_product_registration__v.registration_type_cv__v E2B code is one (1) 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 Gender 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 two (2) 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`)