Configure Workbench PMDA Aggregate Reports

Set up Workbench PMDA Postmarket aggregate reports and generate PMDA Postmarket report tables. To configure Workbench PMDA Reports:

1. Create copies of each preconfigured PMDA Workbench View.
2. Configure view dependencies for each copied Workbench View.
3. Create Workbench Report Definitions for masked and unmasked versions of each report.
4. Create an Aggregate Reporting Group to identify the Products and Studies to include in each report.

Copy the Preconfigured PMDA Views

To configure Workbench PMDA Aggregate Reporting, we recommend you create copies of each preconfigured PMDA Workbench View. These copied Workbench Views act as a baseline for any future Workbench View updates, allowing you to identify and implement changes to your PMDA Workbench Views as appropriate for your organization.

To copy a preconfigured PMDA Workbench View:

1. Navigate to Business Admin > Objects > Workbench Views.
2. Search for the desired PMDA Workbench View.
3. Copy the desired Workbench View.
4. From the Create Workbench View page, populate the fields as follows, then select Save:
   • Name: Enter a name for the PMDA view
   • API Name: Enter an API name ending in __c
   • Description: Enter a description for the PMDA view
5. In the Hierarchical Copy Option dialog that appears, select the Copy Related Records checkbox, then select Save.

PMDA Workbench Views and PMDA Reports

Each preconfigured PMDA Workbench View maps to an unmasked version of a PMDA tabulation, line listing, and log-type report as follows:

PMDA Workbench View Name	Report Name
PMDA PostMarket Principal	N/A—used for configuring Workbench View Dependencies
PMDA PostMarket Principal > Latest	N/A—used for configuring Workbench View Dependencies
PMDA PostMarket Principal > Latest > Case Series Listing	Case Series Report
PMDA PostMarket Principal > Latest > Open Case Listing	Open Cases Report
PMDA PostMarket Principal > Latest > J-NUPR Line Listing	J-NUPR Line Listing Form 7-2
PMDA PostMarket Principal > Latest > J-PSR Line Listing	J-PSR Line Listing of Adverse Events (Form 4)
PMDA PostMarket Principal > Latest > J-PSR Tabulation	J-PSR Cumulative Tabulation of Adverse Events (Form 3)

Configure View Dependencies

For each copied Workbench View that corresponds to a specific report, configure the Workbench View Dependency field to map to its corresponding parent view:

1. Search for and navigate to the copied PMDA Workbench View.
2. In the Dependent Views section, hover over the existing Dependent View record and select Edit.
3. Select a Dependent View as follows based on the copied Workbench View you are editing, then select Save:
   • PMDA Principal > Latest Version: Select the copied PMDA Principal
   • All other report-specific views: Select the copied PMDA Principal > Latest Version
   • PMDA Principal: Not applicable—you do not need to update this view’s Dependent View value
4. Repeat steps 1-3 for all copied Workbench Views.

Create Workbench Report Definitions

To allow users to generate PMDA Workbench aggregate reports, you must create PMDA Workbench Report Definitions. When you create a Workbench Report Definition, the Workbench View you select in the Workbench View field determines which PMDA report Vault creates when a user generates Workbench Reports.

We recommend you create a Workbench Report Definition for each of your copied PMDA Workbench Views.

To create a Workbench Report Definition:

1. Navigate to Workbench Admin > Report Definitions.
2. Select Create.
3. From the Create Report Definition page, populate the fields in the Properties section as follows:
   • Name: Enter a name for the Workbench Report Definition
   • Workbench View: Select the Workbench View you created based on the preconfigured view
   • Report Category: Select Aggregate
   • Report Subcategory: Select PMDA Postmarket
   • API Name: Enter an API name ending in __c
4. In the Layout section, select Select Fields to define the fields that will appear on any resulting Workbench Reports, then select Confirm. If desired, you can replicate the order of the fields as they appear in the relevant PMDA report.
5. Select Save.
6. (Optional) To define a customized tabular structure for the Workbench Report:
   1. By default, each PMDA Excel template is configured with column name values corresponding to the API Name of the preconfigured Workbench View. To ensure your custom Workbench Report Excel files contain the correct data, you must update the values in row 4 of each Excel template to correspond to the API Name of your copied Workbench View.
   2. In Vault, navigate to the Workbench Report Definition and select Edit.
   3. In the Excel Template field within the Advanced Options section, upload the relevant PMDA Excel template.
   4. Select Save.

Create an Aggregate Reporting Group

Create an Aggregate Reporting Group to identify the Products and Studies that the Workbench Report Set should consider.