# Enable DSUR and PBRER Summary Totals and Separate Log Files

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

## About the Feature

The 23R3 release introduced several changes to the DSUR and PBRER aggregate reports. 

The DSUR Cumulative Tabulation of Serious Adverse Events (SAEs) from Clinical Trials and the Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions (SARs) From Clinical Trials now display totals for each MedDRA System Organ Class (SOC) and MedDRA Preferred Term (PT) as well as a grand total.

The PBRER Cumulative Tabulation of Serious Adverse Events from Clinical Trials and the Summary Tabulation of Adverse Drug Reactions (ADRs) from Postmarketing Sources display totals for each SOC and PT as well as a grand total. 

Additionally, DSUR and PBRER log files are now generated as separate files using the new 'Log' Document Classification type. The Summary Tabulation of ADRs from Postmarketing Sources Log also includes additional information to validate the report and correlate the tabulation results with the Case log.

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

## Upload Template: Cumulative Tabulation of SAEs from Clinical Trials

1. Download the following 23R3 template: 
<a class="download-link " href="https://platform.veevavault.help/assets/downloads/saf-cumulativesaefromtrialstemplat.xlsx" target="_blank" rel="noopener">Cumulative Tabulation of Serious Adverse Events from Clinical Trials<i class="fa fa-download" aria-hidden="true"></i></a>
2. Go to **Business Admin > Templates**.
3. Navigate  to **Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Events from Clinical Trials**.
4. Select the existing **Cumulative SAE from Trials Template** hyperlink, then select **Edit**.
5. Under **More Information**, select **Upload File** to upload the Cumulative Tabulation of Serious Adverse Events template.
6. Select **Save**.

**Result**

The 23R3 template for **Cumulative Tabulation of SAEs from Clinical Trials** has been added to your Vault.

## Upload Template: Cumulative Tabulation of SARs from Clinical Trials

1. Download the following 23R3 template:
<a class="download-link " href="https://platform.veevavault.help/assets/downloads/saf-cumulativesarfromtrialstemplate.xlsx" target="_blank" rel="noopener">Appendix: Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials<i class="fa fa-download" aria-hidden="true"></i></a>
2. Go to **Business Admin > Templates**.
3. Navigate to **Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Reactions from Clinical Trial**.
4. Select the existing **Cumulative SAR Trials** hyperlink, then select **Edit**.
5. Under **More Information**, select **Upload File** to upload the Cumulative Tabulation of SARs template.
6. Select **Save**.

**Result**

The 23R3 template for **Cumulative Tabulation of SARs from Clinical Trials** has been added to your Vault.

## Upload Template: Summary ADR from Postmarketing Sources

1. Download the following 23R3 template:
<a class="download-link " href="https://platform.veevavault.help/assets/downloads/saf-summaryadrfrompostmarketingsou.xlsx" target="_blank" rel="noopener">Summary ADR from Postmarketing Sources<i class="fa fa-download" aria-hidden="true"></i></a>
2. Go to **Business Admin > Templates**.
3. Navigate to **Template > Aggregate Summary Tabulation > Summary ADR from Postmarketing Sources**.
4. Select the existing **Summary ADR from Postmarketing Sources** hyperlink, then select **Edit**.
5. Under **More Information**, select **Upload File** to upload the Cumulative Tabulation of ADRs template.
6. Select **Save**.

The 23R3 template for **Summary ADR from Postmarketing Sources** has been added to your Vault.

## Grant Permissions to 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**.

## Enable the New Templates

Ensure you have uploaded the templates described in the previous sections (Cumulative Tabulation of SAEs, Appendix: Cumulative Tabulation of SARs, and Summary Tabulation of ADRs from Postmarketing Sources).

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

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  <div class="alert alert-info" role="alert">
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    <div class="alert-text">
      <p><strong>Note</strong>: If you are currently using the new templates and need to revert to the old templates, you must manually reupload the old templates before clearing the checkbox in step 3.</p>
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