Aggregate report templates allow for quick creation of aggregate reports from a configurable template file.

About Aggregate Report Templates

Workbench generates aggregate tabulations and reports from templates. Admins can configure aggregate Excel templates, for example, to generate custom-branded reports for certain organizations.

Standard Workbench Aggregate Report Templates

The tables below provide links to download the current Safety Workbench aggregate report Excel templates for the following aggregate reports:

DSUR Templates

Download and edit the following templates to use for Workbench DSUR aggregate report generation.

Report Tabulation Latest Version
Cumulative Tabulation of Serious Adverse Events from Clinical Trials (masked version) 25R2
Cumulative Tabulation of Serious Adverse Events from Clinical Trials (unmasked version) 25R2
Interval Line Listings of Serious Adverse Reactions (masked version) 25R2
Interval Line Listings of Serious Adverse Reactions (unmasked version) 25R2
Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials (masked version) 25R2
Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials (unmasked version) 25R2
List of Subjects Who Died During the Reporting Period (masked version) 25R2
List of Subjects Who Died During the Reporting Period (unmasked version) 25R2
Case Series Report (masked version) 25R2
Case Series Report (unmasked version) 25R2
Open Cases Report (masked version) 25R2
Open Cases Report (unmasked version) 25R2

PADER Templates

Download and edit the following templates to use for Workbench PADER aggregate report generation.

Report Tabulation Latest Version
Summary of ADR Tabulation Post Market (including nullified Cases) 24R3
Summary of ADR Tabulation Post Market (excluding nullified Cases) 24R3
15 Day and Non-15 Day Summary Reports (including nullified Cases) 24R3
15 Day and Non-15 Day Summary Reports (excluding nullified Cases) 24R3
Interval Line Listings (including nullified Cases) 25R1
Interval Line Listings (excluding nullified Cases) 25R1
Malfunction Line Listing (including nullified Cases) 25R1
Malfunction Line Listing (excluding nullified Cases) 25R1
Malfunction Tabulation (including nullified Cases) 25R1
Malfunction Tabulation (excluding nullified Cases) 25R1
Line Listing Summary for Combination Products (including nullified Cases) 25R1
Line Listing Summary for Combination Products (excluding nullified Cases) 25R1
Cases Submitted under other NDA's (including nullified Cases) 25R1
Cases Submitted under other NDA's (excluding nullified Cases) 25R1

PBRER Templates

Report Tabulation Latest Version
Summary Tabulation of ADRs from Postmarketing Sources (masked version) 25R2
Summary Tabulation of ADRs from Postmarketing Sources (unmasked version) 25R2
Cumulative Tabulation of Serious Adverse Events from Clinical Trials (masked version) 25R2
Cumulative Tabulation of Serious Adverse Events from Clinical Trials (unmasked version) 25R2
Interval Line Listings of Serious Adverse Reactions (masked version) 25R2
Interval Line Listings of Serious Adverse Reactions (unmasked version) 25R2
Case Series Report (masked version) 25R2
Case Series Report (unmasked version) 25R2
Open Cases Report (masked version) 25R2
Open Cases Report (unmasked version) 25R2

SAR Templates

Download and edit the following templates to use for Workbench SAR aggregate report generation.

Report Tabulation Latest Version
SAR Line Listing 24R3
SAR Tabulated by PT 24R3
SAR Tabulated by SOC, PT 24R3
SUSAR Line Listing 25R1