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
- Download the following 23R3 template:
Cumulative Tabulation of Serious Adverse Events from Clinical Trials - Go to Business Admin > Templates.
- Navigate 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 template.
- 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
- Download the following 23R3 template:
Appendix: Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials - Go to Business Admin > Templates.
- Navigate to Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Reactions from Clinical Trial.
- Select the existing Cumulative SAR Trials hyperlink, then select Edit.
- Under More Information, select Upload File to upload the Cumulative Tabulation of SARs template.
- 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
- Download the following 23R3 template:
Summary ADR from Postmarketing Sources - Go to Business Admin > Templates.
- Navigate to Template > Aggregate Summary Tabulation > Summary ADR from Postmarketing Sources.
- Select the existing Summary ADR from Postmarketing Sources hyperlink, then select Edit.
- Under More Information, select Upload File to upload the Cumulative Tabulation of ADRs template.
- Select Save.
The 23R3 template for Summary ADR from Postmarketing Sources has been added to your Vault.
Grant Permissions to Log Document Type
- Go to Admin > Configuration > Document Types.
- Navigate to Aggregate Reports > Summary Tabulation > Log.
- From the All Actions menu (
) select Edit Details. - Select the Security tab.
- Under Default Settings for New Documents, add roles to the Editors, Viewers, and Consumers fields as required for your organization.
- 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).
- Go to Admin > Settings > Aggregate Report Settings.
- Select Edit.
- In the DSUR / PBRER section, enable the Use templates with calculated totals for tabulations, once uploaded checkbox.
- Select Save.
Note 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.
