Configure Aggregate Report Templates

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

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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 users 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. Vault Online Help 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 users prepare aggregate reports.

  1. On the Business Admin tab, go to Documents & Binders.
    The Document & Binder Templates page appears.
  2. Expand Aggregate Reports, and then locate and select the type of report template that you want to modify.
  3. In the top-right corner, select Create > Document Template.
    Create Document Template
    The Create Document Template page appears.
  4. 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.
  5. Enter the Label.
    When users create documents from templates, they see this value in the list of available templates.
  6. (Optional) Modify the Name.
    This value does not appear to end users. The system reads this name through the API.
  7. Set the Status.
    If set to Inactive, users cannot see the template when adding content.
  8. Select Choose and select a file to attach.
    Once attached, the file name appears next to the Choose button.
  9. To create the template, select Save.

Standard Table Templates

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

Report Type Version Updated Report Tabulation Name and Location Download
Report Type Version Updated Report Tabulation Name and Location Download
DSUR, PBRER 20R2

Name: Interval Line Listings of SARs (interval_line_listings_template__c)

Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions

DSUR (Appendix) 20R2

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

DSUR (Appendix) 20R2

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

DSUR,
PBRER
20R2

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

PBRER 20R2

Name: Interval Line Listings of SARs (interval_line_listings_template__c)

Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions

PBRER 20R2

Name: Summary ADR from Postmarketing Sources (summary_adr_postmarket_template__c)

Location: Template > Aggregate Summary Tabulation > Summary ADR from Postmarketing Sources

PADER 21R1

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

PADER 20R2

Name: PADER Interval Line Listings Template (pader_interval_line_listings_template__c)

Location: Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions

PADER 21R1

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

PADER (Appendix) 21R1

Name: Non-Primary Suspect Product Report (nonprimary_suspect_product_report__c)

Location: Template > Aggregate Summary Tabulation > Non-Primary Suspect Product Report

Learn More: Upload Template: Appendix Non-Primary Suspect Product Report

PADER (Appendix) 21R1

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

PSUR 21R1

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: Add the Cumulative Summary of Tabulations of Adverse Events Template

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
PSUR 21R1

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: Add the CIOMS II Line Listing Template

Administrators can manage these templates in Business Admin > Documents & Binders under Base Document > Template > Aggregate Summary Tabulation.

Aggregate Summary Tabulation Templates
Aggregate Summary Tabulation Templates

Edit an Aggregate Summary Tabulation Template

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

  1. On the Business Admin tab, go to Documents & Binders.
    The Document & Binder Templates page appears.
  2. Expand Template > Aggregate Summary Tabulation, and then select the template that you want to edit.
    The tabulation template appears in the right pane.
  3. To download the file, hover over the template file, and then select Download Button.
  4. Edit and save the file as required.
    For tabulation templates, you can edit the following elements:
    • Document titles
    • Headers and footers
    • Column formatting

    Note Editing table cell contents may cause issues with data generation.

  5. Return to the template page in Vault Safety.
  6. To open the template, select the template name link.
  7. Select Edit.
  8. Select Upload File, and then open the file.
  9. Select Save.

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. Vault Online Help 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. Vault Online Help 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.

Note You cannot delete controlled document templates directly from the Admin area. Vault Online Help provides details about deleting controlled document templates.


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