Configure Workbench PBRER Aggregate Reports

Learn how to set up PBRER aggregate reports in Workbench.

Workbench provides Periodic Benefit-Risk Evaluation Report (PBRER) table generation capabilities. Vault generates the following standard PBRER tabulations and line listings, with support for masked and unmasked versions of each:

• Summary Tabulation of ADRs from Postmarketing Sources
• Cumulative Tabulation of Serious Adverse Events from Clinical Trials
• Interval Line Listings of Serious Adverse Reactions

In addition to the standard PBRER tabulations and line listings, Vault can produce masked and unmasked versions of the following log-type reports:

• Case Series Report
• Open Cases Report

After you have configured this feature, see the following article to learn more: Create Workbench PBRER Aggregate Reports.

Overview

To configure Workbench PBRER Aggregate Reports:

1. Create copies of each preconfigured PBRER 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 PBRER Views

To configure Workbench PBRER Aggregate Reporting, we recommend you create copies of each preconfigured PBRER 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 PBRER Workbench Views as appropriate for your organization.

To copy a preconfigured PBRER Workbench View:

1. Navigate to Business Admin > Objects > Workbench Views.
2. Search for the desired PBRER 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 PBRER view
   • API Name: Enter an API name ending in __c
   • Description: Enter a description for the PBRER view
5. In the Hierarchical Copy Option dialog that appears, select the Copy Related Records checkbox, then select Save.

PBRER Workbench Views and PBRER Reports

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

PBRER Workbench View Name	Report Name
DSUR / PBRER Principal	N/A—used for configuring Workbench View Dependencies
DSUR / PBRER Principal > Latest Version	N/A—used for configuring Workbench View Dependencies
DSUR / PBRER Principal > Latest Version > Summary Tabulation of ADRs from Postmarketing Sources (Masked)	Summary Tabulation of ADRs from Postmarketing Sources, masked version
DSUR / PBRER Principal > Latest Version > Summary Tabulation of ADRs from Postmarketing Sources (Unmasked)	Summary Tabulation of ADRs from Postmarketing Sources, unmasked version
DSUR / PBRER Principal > Latest Version > SAE Cumulative Tabulation (Masked)	Cumulative Tabulation of Serious Adverse Events from Clinical Trials, masked version
DSUR / PBRER Principal > Latest Version > SAE Cumulative Tabulation (Unmasked)	Cumulative Tabulation of Serious Adverse Events from Clinical Trials, unmasked version
DSUR / PBRER Principal > Latest Version > SAR Line Listing (Masked)	Interval Line Listings of Serious Adverse Reactions, masked version
DSUR / PBRER Principal > Latest Version > SAR Line Listing (Unmasked)	Interval Line Listings of Serious Adverse Reactions, unmasked version
DSUR / PBRER Principal > Latest Version > PBRER Case Series Report (Masked)	Case Series Report, masked version
DSUR / PBRER Principal > Latest Version > PBRER Case Series Report (Unmasked)	Case Series Report, unmasked version
DSUR / PBRER Principal > Latest Version > PBRER Open Cases (Masked)	Open Cases Report, masked version
DSUR / PBRER Principal > Latest Version > PBRER Open Cases (Unmasked)	Open Cases Report, unmasked version

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 PBRER 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:
   • DSUR / PBRER Principal > Latest Version: Select the copied DSUR / PBRER Principal
   • All other report-specific views: Select the copied DSUR / PBRER Principal > Latest Version
   • DSUR / PBRER 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 PBRER Workbench aggregate reports, you must create PBRER Workbench Report Definitions. When you create a Workbench Report Definition, the Workbench View you select in the Workbench View field determines which PBRER report Vault creates when a user generates Workbench Reports.

We recommend you create a Workbench Report Definition for each of your copied PBRER 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 PBRER
   • 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 PBRER report.
5. Select Save.
6. (Optional) To define a customized tabular structure for the Workbench Report:
   1. By default, each PBRER 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 PBRER 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.