Configure Aggregate Report Templates

Document templates allow quick creation of aggregate report documents from a configurable template file.

About Aggregate Report Templates

The system generates aggregate tabulations and reports from templates. Admins can configure aggregate document templates, for example, to generate custom branded reports for certain organizations.

When you generate aggregate report documents or tables, Vault uses the template as the source file for the new document.

Creating documents from templates bypasses the content upload process and allows for more consistent document creation. Managing Document Templates provides more information on creating and managing document templates.

Add an Aggregate Report Template

Create an aggregate report template to use as a base document when you prepare aggregate reports.

Go to Business Admin > Templates > Documents & Binders. The Document & Binder Templates page appears.
Expand Aggregate Reports, and then locate and select the type of report template that you want to modify.
In the top-right corner, select Create > Document Template. The Create Document Template page appears.
In the Type field, select one of the following options:
- Basic Document Template: Use an Admin-uploaded document as the source file.
- Controlled Document Template: Point to a Vault document in the Steady state as the source file. Both users and admins can edit controlled templates.
Enter the Label. When users create documents from templates, they see this value in the list of available templates.
(Optional) Modify the Name. This value does not appear to end users. The system reads this name through the API.
Set the Status. If set to Inactive, users cannot see the template when adding content.
Select Choose and select a file to attach. Once attached, the file name appears next to the Choose button.
To create the template, select Save.

Standard Table Templates

You can manage aggregate report templates in Business Admin > Documents & Binders under Base Document > Template > Aggregate Summary Tabulation.

The following table provides links to download the current Vault Safety aggregate and periodic report table .xlsx templates:

Report Type	Report Tabulation Name and Location	Latest Version	Previous Version
CIOMS II	Name: CIOMS II Line Listing (`cioms_ii_line_listing__c`) Location: Template > Aggregate Summary Tabulation > CIOMS II Line Listing	22R2
DSUR (Appendix)	Name: Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials (`cumulative_sar_trials__c`) Location: Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Reactions from Clinical Trial Learn More: Upload Template: Appendix Cumulative Tabulation of SARs	23R3
DSUR (Appendix)	Name: List of Subjects Who Died During the Reporting Period (`list_of_subjects_died_trials__c`) Location: Template > Aggregate Summary Tabulation > List of Subjects Who Died During Reporting Period Learn More: Upload Template: Appendix List of Subjects Who Died During the Reporting Period	20R2
DSUR, PBRER	Name: Cumulative Tabulation of Serious Adverse Events from Clinical Trials (`cumulative_sae_trials_template__c`) Location: Template > Aggregate Summary Tabulation > Cumulative Tabulation of Serious Adverse Events from Clinical Trials	23R3
DSUR, PBRER	Name: Interval Line Listings of SARs (`interval_line_listings_template__c`) Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions	20R2
PBRER	Name: Summary ADR from Postmarketing Sources (`summary_adr_postmarket_template__c`) Location: Template > Aggregate Summary Tabulation > Summary ADR from Postmarketing Sources	23R3
PADER	Name: 15 Day and Non-15 Day Summary Reports (`pader_summary_15_non_15_day_template__c`) Location: Template > Aggregate Summary Tabulation > 15 Day and Non-15 Day Summary Reports Learn More: Replace PADER 15 Day and Non-15 Day Reports Template	23R1	21R1
PADER	Name: PADER Interval Line Listings Template (`pader_interval_line_listings_template__c`) Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions Learn More: Replace PADER Interval Line Listings Template	23R1	20R2
PADER	Name: PADER Summary of ADR Tabulation Post market (`pader_summary_adr_postmarket_template__c`) Location: Template > Aggregate Summary Tabulation > Summary ADR from Postmarketing Sources Learn More: Replace PADER Summary Tabulation of ADRs from Postmarket Template	23R1	21R1
PADER (Appendix)	Name: List of Death Cases (Postmarketing) (`list_of_death_cases__c`) Location: Template > Aggregate Summary Tabulation > List of Death Cases Learn More: Upload Template: Appendix List of Death Cases	21R1
PADER (Appendix)	Name: Non-Primary Suspect Product Report (`nonprimary_suspect_product_report__c`) Location: Template > Aggregate Summary Tabulation > Non-Primary Suspect Product Report Learn More: Replace Appendix: Non-Primary Suspect Product Report	23R1	21R1
PMDA Post-Market	Name: J-NUPR Non-Serious Unlisted Periodic Report (`jnupr_nonserious_unlisted_periodic_rep__c`) Location: Template > Aggregate Summary Tabulation > J-NUPR Non-Serious Unlisted Periodic Report Learn More: Upload Template: J-NUPR Non-Serious Unlisted Periodic Report	24R1
PMDA Post-Market	Name: J-PSR Line Listing of Adverse Events (`jpsr_line_listing_of_adverse_events__c`) Location: Template > Aggregate Summary Tabulation > J-PSR Line Listing of Adverse Events Learn More: Upload Template: J-PSR Line Listing of Adverse Events	24R2
PMDA Post-Market	Name: J-PSR Tabulation of Adverse Events (`jpsr_tabulation_of_adverse_events__c`) Location: Template > Aggregate Summary Tabulation > J-PSR Tabulation of Adverse Events Learn More: Upload Template: J-PSR Tabulation of Adverse Events	24R2
PSUR	Name: CIOMS II Line Listing Template for PSUR Reports (`psur_ciomsii_line_listings__c`) Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions Learn More: Upload the CIOMS II Line Listing Template	21R1
PSUR	Name: PSUR - Cumulative Summary of Tabulations of Adverse Events Template (`psur_summary_tabulations_of_ae__c`) Location: Template > Aggregate Summary Tabulation > PSUR - Cumulative Summary of Tabulations of Adverse Events Learn More: Upload Template: PSUR - Cumulative Summary of Tabulations of Adverse Events This template generates both of the following tabulations, separated by tabs in the Excel document: Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions Summary Tabulation of Serious Unlisted Adverse Drug Reactions	23R3

Aggregate Report Template Considerations

The .xlsx templates that Vault Safety uses to generate the aggregate reports provide great flexibility. There are a few considerations when generating these reports:

Cells are limited to a maximum of 32,767 characters.
Rows are limited to a maximum height of 409 points. While the cell’s content in the file is not lost, any text that extends beyond this limit will not appear on the screen.
Sheets are limited to a maximum of 1,048,576 rows.

Edit an Aggregate Summary Tabulation Template

To customize an aggregate report table template, we recommend that you edit the system-provided preconfigured templates.

Go to Business Admin > Templates > Documents & Binders. The Document & Binder Templates page appears.
Expand Template > Aggregate Summary Tabulation, and then select the template that you want to edit. The tabulation template appears in the right pane.
To download the file, hover over the template file, and then select .
Edit and save the file as required. For tabulation templates, you can edit the following elements:
- Document titles
- Headers and footers
- Column formatting
Return to the template page in Vault Safety.
To open the template, select the template name link.
Select Edit.
Select Upload File, and then open the file.
Select Save.

Note: Editing table cell content may cause issues with data generation.

Note: As of the 23R3 release, the formatting of the following aggregate reports is fixed and will override any custom formatting with the exception of page headers and footers, and the table header rows:

Interval Line Listings of Serious Adverse Reactions (DSUR and PBRER)
Cumulative Tabulation of Serious Adverse Events From Clinical Trials (DSUR and PBRER)
Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials (DSUR and PBRER)
Summary Tabulation of Serious Unlisted Adverse Drug Reactions (PSUR)
Summary Tabulation of Serious Listed and Non Serious Adverse Drug Reactions (PSUR)

Use Merge Fields in Report Table Templates

Merge fields allow you to create templates that auto-populate with field values like product name, organization, and receipt date. Using Merge Fields for Microsoft Word & Excel provides guidance on using merge fields.

Consider the following requirements before you add merge field tokens to aggregate or periodic report table templates:

To use merge fields in an aggregate report table template, the template file must be in the .xlsx format. See Standard Table Templates for the standard Vault Safety .xlsx templates.
In any document for which you want to generate merge field tokens, the Merge Fields shared document field must be associated with the document type. Configuring Merge Fields for Microsoft Word & Excel provides more information on enabling merge fields.

Note: In Vaults created before Vault Safety 20R2, the system-provided default table templates are in the .xlsm file format, which is not supported for merge fields.

Template Types

You can create basic or controlled templates. Choose the template that best suits your security requirements.

Basic Templates

Basic document templates use an Admin-uploaded document as the template’s source file.

You can create multiple basic document templates from a single source file by uploading the same source file each time you create a new basic template.

Basic document templates are created and managed in Admin > Document & Binder templates.

Controlled Templates

Controlled document templates point to a Steady state Vault document, referred to as a template document, as the source file for the template.

Documents derived from the template inherit a Based On (and Original Source, if enabled) relationship with the template document. You can create multiple controlled document templates in any location in the document type hierarchy, but you can’t use a single document version as the template document for more than one controlled document template.

Both Admins and users can create controlled document templates, but these templates are mainly managed by users.

Disable and Delete Templates

Disabling a template makes it temporarily unavailable to users creating new documents. Setting the disabled template back to Active makes it available again.

Deleting a template permanently removes it from the Vault and deletes the attached file or the association to the template document. Neither action affects documents created from the template.

Disable a Basic or Controlled Template

To disable a basic or controlled template, perform one of the following actions:

From the template list panel, select Set to Disabled from the Actions menu.
From the template detail page, select Edit, change the status, and then select Save.

Delete a Basic Template

To delete a basic template, perform one of the following actions:

From the template list panel, select Delete from the Actions menu.
From the template details page, select Delete.