Aggregate Reports Overview

You can generate and author ICH-compliant aggregate reports directly in your Vault. Safety processes relevant Case data within the specified time period to generate aggregate report tables and populate their data. You can use a standard template to create and author the aggregate report document. Business Admins can configure custom report templates to align with organizational requirements.

Create, view, and manage Aggregate Report records from the Aggregate Reports tab. If you don’t see the tab in your Vault, you may not have permission to participate in aggregate report workflows. By default, only users assigned the Head of Safety or Safety Writer role can view and edit aggregate reports.

Supported Aggregate Reports

Veeva Safety supports the following aggregate report types, based on the listed regulatory guidelines:

• Development Safety Update Report (DSUR): ICH E2F
• Periodic Adverse Drug Experience Report (PADER): FDA U.S. PADER
• Periodic Benefit-Risk Evaluation Report (PBRER): ICH E2C(R2), GvP Module VII
• Periodic Safety Update Report (PSUR): ICH E2C(R1)
• Council for International Organizations of Medical Sciences (CIOMS) II: ICH E2C(R1)
• Pharmaceuticals and Medical Devices Agency (PMDA) Post-Market Non-Serious (NUPR): Guide to Electronic Reporting of Adverse Drug Reactions and Infectious Diseases, E2B(R3)-Compliant (2022 Edition)

Overview of Aggregate Report Setup

The following steps outline the process to set up and prepare aggregate reports:

1. Your Admin must set up a Reporting Product Family with the Products and Studies to include in the report.
2. Your Admin can configure the following, as applicable:
   1. Datasheets to calculate expectedness for some aggregate reports (CIOMS II, DSUR, PBRER, and PSUR) based on listed events. If no Datasheets exist for the Study or Product, Vault considers all adverse events to be unexpected for these reports.
   2. Custom aggregate report templates. If custom templates are not configured, reports are generated with the standard templates.
   3. Extend the definition of Suspect to Drug Not Administered.
3. Users create the appropriate Aggregate Report. When creating the report, you specify report settings such as the Product Family, States to Include, and Reporting Period.
4. Once you create the Aggregate Report, Vault initiates the workflow to assist with the aggregate report generation. Vault assigns tasks to users to prepare the report.
5. Vault generates the aggregate report tabulations.
6. Users proceed with a multi-document workflow to complete aggregate report authorship and coordinate the submission outside of Vault.

Default Aggregate Reporting Workflow

The default aggregate report workflow occurs in the following stages, indicated by the lifecycle stages chevron panel:

1. Pending: When you create the Aggregate Report, it enters Pending. During this stage, you set up the record, and then review and confirm the report details.
2. Authorship: After you review and confirm the report details, the report enters Authorship. During this stage, you can create the aggregate report document from the appropriate report template and then assign user tasks to prepare and approve the report.
3. Submission: Once the report authoring is completed and approved, the report enters Submission. During this stage, you can coordinate the submission outside of Vault and then mark the submission as complete to finalize the aggregate report.
4. Complete: After you mark the report as submitted, the report enters Complete. Vault creates a new Aggregate Report for the next upcoming reporting deadline according to the time period configured in the reporting family.