Configure Aggregate Reporting Families

Before you can create an aggregate report, you must configure the product Reporting Family.

About Aggregate Reporting Families

To enable aggregate report authoring in Vault Safety, you must set up the Reporting Family. The Reporting Family defines which products and studies to include in an aggregate report and the reporting time period.

Create a Reporting Family

Note: The Base Reporting Family object type is deprecated and should not be used for aggregate reporting. We recommend that all aggregate reporting families be of the type Product Family. This recommendation applies both to creating new aggregate report tabulations and re-generating tabulations on existing aggregate reports already setup in the system.

Go to Business Admin > Objects > Reporting Families.
Select Create.
In the Create Reporting Family window, select Product Family, and then select Continue.
Complete these fields on the Create Reporting Family page.
Select Save.

Field	Description
Name	Enter a name for the product family. Note: If your organization uses Reporting Families for aggregate reporting, we recommend that product family names have a maximum of 75 characters. Longer names may impact report generation.
Organization	Select the organization that is responsible for preparing the report.
IBD	Select the international birth date (IBD) for the product family. This field is informational only, and is not used in aggregate reporting.
Reporting Period (Months)	Enter the number of months that the reporting period spans. The time period you enter in this field determines the reporting schedule the system uses to automatically generate subsequent aggregate reports when the Generate Next Aggregate Report Record action is triggered.

Add Reporting Family Members

Note: For PADER reporting families, add both the Product and Study to ensure all Study Cases are included. For PMDA Post-Market reporting families, also add Product Registrations to ensure compliance when reporting Post-Market Serious Cases to Japan.

You must configure the Reporting Family for aggregate reports.

Add a Product

To add a Product:

On the Reporting Family page, expand Products.
Select Create. The Create Reporting Family Member window appears.
In the Product field, select the Product to include in the report. The products that appear are filtered by the organization.
Select Save.

Result

The Product is added to the Reporting Family. Any Studies associated with the Product are also added to the Reporting Family. Add additional Products as required.

Add a Study

If the report must include a Study Product that does not share registration details with a record in the Product library, add the Study.

On the Reporting Family page, expand Studies.
Select Create. The Create Reporting Family Member window appears.
In the Study field, select the Study to include in the report. The studies that appear are filtered by the organization.
Select Save.

Result

The Study and associated Products are added to the Reporting Family. Add additional Studies as required.

Add a Product Registration (PMDA J-PSR Only)

For PMDA Post-Market reports, add Product Registrations that are reportable to Japan to populate J-PSR Cumulative Tabulation of Adverse Events Form 3 and J-PSR Line Listing of Adverse Events Form 4 tabulations:

On the Reporting Family page, expand Product Registrations.
Select Create. The Create Product Registration window appears.
Complete the fields:
1. In the Product field, select the Product with the relevant Product Registration.
2. In the Product Registration field, select the applicable Product Registration.
3. In the Destination field, select an option from the picklist.
4. In the Origin field, select an option from the picklist.
Select Save.

Result

The Product Registration is added to the Reporting Family. Add other Product Registrations as required.

Add a Substance (PSUR Only)

For PSUR line listings, add Substance Reporting Family Members to include products with the specified substance.

On the Reporting Family page, expand Substances.
Select Create. The Create Reporting Family Member window appears.
In the Substance field, select the Substance to include in the report. The Substances that appear are filtered by the preconfigured Substances for the selected organization.
Select Save.

Result

The Substance is added to the Reporting Family. Add additional substances as required.

Create an Aggregate Report

On the Reporting Family page, you can add aggregate reports from the Aggregate Reports section.

The following pages provide specific instructions for each report type: