Vault Safety supports creating and authoring aggregate reports.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Aggregate Reports
You can generate and author ICH-compliant aggregate reports directly in your Vault. Vault Safety processes relevant Case data within the specified time period to generate aggregate report tables and populate their data.
Table generation is only available in environments with a Vault Safety application license. SafetyDocs Vaults don’t support this functionality.
You can use a system-provided template to create and author the aggregate report document. Business Administrators 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 Aggregate Reports tab, 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
The following table outlines the types of aggregate reports that Vault Safety supports, and the regulatory guideline each report is based on:
| Report Type | Regulatory Guideline |
|---|---|
| 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) |
| CIOMS II | ICH E2C(R1) |
| 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 list outlines the process to set up and prepare aggregate reports:
- Your Admin must first set up a Reporting Product Family with the Products and Studies to include in the report.
- Your Admin can optionally set up Datasheets to calculate expectedness for some aggregate reports (CIOMS II, DSUR, PBRER, and PSUR) based on listed events. If no Datasheets are set up for the Study or Product, all adverse events are considered unexpected for these reports.
- If required, your Admin can configure custom aggregate report templates for your organization. If custom templates are not configured, reports are generated with the system-provided templates.
- If required, your Admin can configure Case Products with a Drug Role of Drug Not Administered to be evaluated as suspect.
- Users create the appropriate Aggregate Report. When creating the Aggregate Report, you specify report settings such as the Product Family, States to Include, and Reporting Period.
- Once the Aggregate Report has been created, Vault Safety initiates the Aggregate Report workflow to assist with the aggregate report generation. Tasks are assigned to users to prepare the report.
- Vault generates the Aggregate Report tabulations.
- Users proceed with a multi-document workflow to complete aggregate report authorship and coordinate the submission outside of Vault Safety.
Default Aggregate Reporting Workflow
The default aggregate report workflow occurs in four (4) stages.
Note: Your organization may have a unique aggregate report workflow configuration. Refer to your standard operating procedures for more information.
The Lifecycle Stages Chevron panel at the top of the aggregate report page shows what stage the report is in:
Pending
When you create the Aggregate Report record, it enters the Pending stage. During the Pending stage, you set up the Aggregate Report record, and then review and confirm the report details.
Authorship
After you review and confirm the report details, the report enters the Authorship stage. During the Authorship stage, you can create the aggregate report document from the appropriate report template and then assign user tasks to prepare and approve the report.
Submission
Once the aggregate report authoring is completed and approved, the report enters the Submission stage. During the Submission stage, you can coordinate the submission outside of Vault Safety and then mark the submission as complete to finalize the aggregate report.
Complete
After you mark the aggregate report as submitted, the report enters the Complete stage. Vault automatically creates a new Aggregate Report record for the next upcoming reporting deadline according to the time period configured in the reporting family.