About the Feature
As of the 23R2 release, DSUR and PBRER Line Listings now list all suspect products for a given Case. Previously, only the primary suspect Product was listed. In addition, the DSUR and PBRER now include a Breakdown of Investigative Medicinal Products (IMP) tabulation for Serious Adverse Events (SAEs) and Serious Adverse Reactions (SARs) (for DSUR only) from Clinical Trials. This is particularly important for combination therapies and provides more accurate DSUR and PBRER reporting.
For more information, see Create DSUR Aggregate Reports and Create PBRER Aggregate Reports.
Update the Cumulative Tabulation Templates
In Vaults created after 23R2, these templates are updated by default. For Vaults created prior to 23R2, you must upload these templates.
The following sections describe how to upload these templates to your Vault.
Upload Template: Cumulative Tabulation of Serious Adverse Events from Clinical Trials
- Download the following 23R2 template:
Cumulative Tabulation of Serious Adverse Events from Clinical Trials - Go to Business Admin > Templates.
- Expand the folders to Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Events from Clinical Trials.
- Select the existing Cumulative SAE from Trials Template hyperlink, then select Edit.
- Under More Information, select Upload File to upload the Cumulative Tabulation of Serious Adverse Events from Clinical Trials template.
- Select Save.
Result
The 23R2 template for Cumulative Tabulation of Serious Adverse Events from Clinical Trials has been added to your Vault.
Upload Template: Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials
- Download the following 23R2 template:
Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials - Go to Business Admin > Templates.
- Expand the folders to Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials.
- Select the existing Cumulative SAR Trials hyperlink, then select Edit.
- Under More Information, select Upload File to upload the Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials template.
- Select Save.
Result
The 23R2 template for Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials has been added to your Vault.
