Enable Masked Aggregate Reports and DSUR Appendices

With the 20R2 release, Safety introduces support for the following DSUR regional appendices and masked DSUR tabulations:

  • Masked DSUR: You can generate both masked and unmasked versions of the Cumulative Tabulation of SAEs and Interval Line Listings. This option is controlled by the DSUR Generate Masked Documents field.
  • DSUR Appendices: You can generate the following DSUR appendices for regional reporting, controlled by the DSUR Documents to Generate field:
    • Appendix Cumulative Tabulation of SARs
    • Appendix List of Subjects Who Died During the Reporting Period

26R2 Update: Interval Tabulations for DSUR

With the 26R2 release, Safety introduces support for the following DSUR interval tabulations:

  • Appendix: Interval Tabulation of SARs
  • Appendix: Interval Tabulation of SARs

To configure your Vault for this feature, see Configure Interval Tabulations for DSUR.

Create DSUR Aggregate Reports provides more information on how to use this feature.

Update Aggregate Report Layout

  1. In the Admin area, go to Configuration > Objects > Aggregate Report > Layouts, and then select Aggregate Report Detail Page Layout.
  2. In the Details section, select Add, and then add the following fields from the drop-down:
    • Documents to Generate: This field is required for generating DSUR appendices.
    • Generate Masked Documents: This field is required for generating masked DSURs.
  3. Select Save at the top right of the page.

Result

Your Vault can generate both masked and unmasked documents for DSUR Aggregate Reports.

Enable DSUR Appendices Generation

Document Types for the Appendix Cumulative Tabulation of SARs template and Appendix List of Subjects Who Died During the Reporting Period template will already be available in your Vault. To access them, go to Configuration, then Document Types > Base Document > Template > Aggregate Summary Tabulation.

To generate these appendices for a DSUR report, your Administrator will need to add the corresponding templates to your Vault.

Upload Template: Appendix Cumulative Tabulation of SARs

  1. Go to Business Admin > Templates > Documents & Binders.
  2. Expand the folders to Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials.
  3. Select Create, and then select Document Template.
  4. Specify the following details for the template document:
    • Type: Select Basic Document Template.
    • Label: Enter Cumulative SAR Trials.
    • Name: This field should be automatically updated. Ensure the name has been updated to cumulative_sar_trials__c. The template name must match the Document Type Template name or the report will not generate from the template.
    • Status: Ensure this field is set to Active.
  5. Under More Information, upload the Cumulative Tabulation of SARS template. Download the following report table template, and then attach it as the template document: Appendix: Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials.
  6. Select Save.

Result

The template for Appendix Cumulative Tabulation of SARS has been added to your Vault.

(26R2) Configure Interval Tabulations for DSUR

To configure support for DSUR interval tabulations, upload the following templates:

Upload Template: Appendix Interval Tabulation of SARs

To upload the template for the Appendix: Interval Tabulation of SARs:

  1. Navigate to Business Admin > Templates > Documents & Binders.
  2. Expand the folders to Template > Aggregate Summary Tabulation > Interval Tabulation of Serious Adverse Reactions from Clinical Trials.
  3. Select Create, and then select Document Template.
  4. Specify the following details for the template document:
    • Type: Select Basic Document Template.
    • Label: Enter Interval SAR Trials.
    • Name: This field should be automatically updated. Ensure the name has been updated to interval_sar_trials__c. The template name must match the Document Type Template name or the report will not generate from the template.
    • Status: Ensure this field is set to Active.
  5. Under More Information, upload the Interval Tabulation of SARs template. Download the following report table template, and then attach it as the template document: Appendix: Interval Tabulation of Serious Adverse Reactions from Clinical Trials.
  6. Select Save.

Result

The template for Appendix Interval Tabulation of SARs has been added to your Vault.

Upload Template: Appendix Interval Tabulation of SAEs

  1. Navigate to Business Admin > Templates > Documents & Binders.
  2. Expand the folders to Template > Aggregate Summary Tabulation > Interval Tabulation of Serious Adverse Events from Clinical Trials.
  3. Select Create, and then select Document Template.
  4. Specify the following details for the template document:
    • Type: Select Basic Document Template.
    • Label: Enter Interval SAE Trials.
    • Name: This field should be automatically updated. Ensure the name has been updated to interval_sae_trials__c. The template name must match the Document Type Template name or the report will not generate from the template.
    • Status: Ensure this field is set to Active.
  5. Under More Information, upload the Interval Tabulation of SAEs template. Download the following report table template, and then attach it as the template document: Appendix: Interval Tabulation of Serious Adverse Events from Clinical Trials.
  6. Select Save.

Result

The template for Appendix Interval Tabulation of SAEs has been added to your Vault.

Upload Template: Appendix List of Subjects Who Died During the Reporting Period

  1. Go to Business Admin > Templates > Documents & Binders.
  2. Expand the folders to Template > Aggregate Summary Tabulation > List of Subjects Who Died During Reporting Period.
  3. Select Create, and then select Document Template.
  4. Specify the following details for the template document:
    • Type: Select Basic Document Template.
    • Label: Enter List of Subjects Who Died During Reporting Period.
    • Name: Update this field to list_of_subjects_died_trials__c. Do not use the auto-generated name. The template name must match the Document Type Template name or the report will not generate from the template.
    • Status: Ensure this field is set to Active.
  5. Under More Information, upload the List of Subjects Who Died During the Reporting Period template. Download the following report table template, and then attach it as the template document: Appendix: List of Subjects Who Died During the Reporting Period.
  6. Select Save.

Result

The template for Appendix List of Subjects Who Died During the Reporting Period has been added to your Vault.