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 |