Configure Workbench DSUR Aggregate Reports

Learn how to set up DSUR aggregate reports in Workbench.

About Workbench DSURs

Workbench provides Development Safety Update Report (DSUR) table generation capabilities. Vault generates the following standard DSUR tabulations and line listings, with support for masked and unmasked versions of each:

• Cumulative Tabulation of Serious Adverse Events from Clinical Trials
• Interval Line Listings of Serious Adverse Reactions
• Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
• List of Subjects Who Died During the Reporting Period

In addition to the standard DSUR 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 DSUR Aggregate Reports.

Overview

To configure Workbench DSUR Aggregate Reports:

1. Create copies of each preconfigured DSUR 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 DSUR Views

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

To copy a preconfigured DSUR Workbench View:

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

DSUR Workbench Views and DSUR Reports

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

DSUR 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 > 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 > SAR Cumulative Tabulation (Masked)	Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials, masked version
DSUR / PBRER Principal > Latest Version > SAR Cumulative Tabulation (Unmasked)	Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials, unmasked version
DSUR / PBRER Principal > Latest Version > List of Subjects Who Died (Masked)	List of Subjects Who Died During the Reporting Period, masked version
DSUR / PBRER Principal > Latest Version > List of Subjects Who Died (Unmasked)	List of Subjects Who Died During the Reporting Period, unmasked version
DSUR / PBRER Principal > Latest Version > DSUR Case Series Report (Masked)	Case Series Report, masked version
DSUR / PBRER Principal > Latest Version > DSUR Case Series Report (Unmasked)	Case Series Report, unmasked version
DSUR / PBRER Principal > Latest Version > DSUR Open Cases (Masked)	Open Cases Report, masked version
DSUR / PBRER Principal > Latest Version > DSUR 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 DSUR 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 DSUR Workbench aggregate reports, you must create DSUR Workbench Report Definitions. When you create a Workbench Report Definition, the Workbench View you select in the Workbench View field determines which DSUR report Vault creates when a user generates Workbench Reports.

We recommend you create a Workbench Report Definition for each of your copied DSUR 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 DSUR
   • 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 DSUR report.
5. Select Save.
6. (Optional) To define a customized tabular structure for the Workbench Report:
   1. To ensure your custom Workbench Report Excel files contain the correct data, you must update the values in row 4 of each DSUR Excel template to correspond to the API Name of your copied Workbench View. By default, each Excel template is configured with column name values corresponding to the API Name of the preconfigured 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 DSUR 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.