Enable PSUR Summary Totals and Separate Log Files

Learn how to enable summary totals and separate log files for the PSUR in your Vault.

About the Feature

Introduced in the 23R3 release, the PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions and Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions can now display totals for each MedDRA System Organ Class (SOC) and MedDRA Preferred Term (PT), as well as a grand total.

The styling of the tabulation report has also been updated for better usability.

Additionally, Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions Logs are generated separately in a single Log file, using the new “Log” Document Classification type. The Log includes a Report Tab column to distinguish Cases as “Serious Unlisted” or “Serious Listed and Non Serious”.

The following sections describe how to enable this feature in your Vault.

Upload Template: PSUR - Cumulative Summary of Tabulations of Adverse Events

Complete the following steps to upload the PSUR - Cumulative Summary of Tabulations of Adverse Events template:

1. Download the following 23R3 template: PSUR - Cumulative Summary of Tabulations of Adverse Events
2. Go to Business Admin > Templates.
3. Navigate to Template > Aggregate Summary Tabulation > PSUR - Cumulative Summary of Tabulations of Adverse Events.
4. Select the existing PSUR - Cumulative Summary of Tabulations of Adverse Events hyperlink, then select Edit.
5. Under More Information, select Upload File to upload the PSUR - Cumulative Summary of Tabulations of Adverse Events template.
6. Select Save.

Result

The 23R3 template for PSUR - Cumulative Summary of Tabulations of Adverse Events is available in your Vault.

Enable the New Template

Before completing the steps below, ensure you have uploaded the PSUR - Cumulative Summary of Tabulations of Adverse Events template described in the previous section.

1. Go to Admin > Settings > Aggregate Report Settings.
2. Select Edit.
3. In the PSUR section, enable the Use templates with calculated totals for tabulations, once uploaded checkbox.
4. Select Save.

Grant Permissions to the Log Document Type

1. Go to Admin > Configuration > Document Types.
2. Navigate to Aggregate Reports > Summary Tabulation > Log.
3. From the All Actions menu, select Edit Details.
4. Select the Security tab.
5. Under Default Settings for New Documents, add roles to the Editors, Viewers, and Consumers fields as required for your organization.
6. Select Save.