Sections in This Article
- Localized Cases
- Aggregate Reports
- Action Items
- Business Admin (Quick Access)
- Tab Views and Filters
Use the following animation to interact with Vault Safety’s Home page. Note that this vault contains standard configuration and that certain things may appear differently in your vault.
Home is typically the first area you see after logging into a vault.
On the Home tab, you can view or complete your assigned tasks, and review workflows in which you are a participant.
Perform intake on the Inbox tab. Your vault may have an Inbox configured for AERs and/or Inbox Items. Refer to your organization’s standard operating procedures for guidance.
The Inbox organizes reports into a detailed table, providing at-a-glance key information. You can sort the reports in ascending or descending order using any column in the table, such as Product, Organization, Seriousness, Due Date, and more.
Inbox Item Inbox
The Cases tab contains all Vault Safety Cases. You cannot create a Case directly from the Cases tab. To create a Case, you must create an Adverse Event Report from the Inbox tab and then promote the Adverse Event Report to a Case.
Certain vaults may contain the Localized Cases tab for quick access to Localized Cases.
Vault Safety supports both manual and automated Submissions of Individual Case Safety Reports (ICSRs) to the FDA. Manage Submissions from the Transmissions tab.
If you do not see the Transmissions tab, you may not have permission to participate in Submission workflows. By default, only users assigned the Head of Safety and Distribution Manager roles can participate in Submissions.
Vault Safety supports ICH-compliant aggregate reports, including table generation and collaborative document editing. The Aggregate Reports tab is where you author and manage aggregate reports.
If you do not 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 and Safety Writer roles can view and edit aggregate reports.
Use reports to generate and analyze information about business operations in your vault at any point-in-time. You can use reports to organize, analyze, and share any data related to your Cases, documents, and processes. Create, view, and manage reports from the Analytics > Reports tab.
Use dashboards to visualize report data for at-a-glance understanding of key metrics. Create, view, and manage dashboards from the Analytics > Dashboards tab.
The dashboards you see on the Dashboards tab are those that you have created or that another user has created and shared with you.
Use the Library tab to manage and collaborate on documents, including case narratives, aggregate reports, and case attachments.
To assign tasks to case processors, such as requests for follow-up information, create an action item on a Case or Adverse Event Report. You can manage action items for all Cases from the Action Items tab:
Business Admin (Quick Access)
The Business Admin (Quick Access) tab only appears for Administrators and provides easy access to core admin actions and areas they need to set up.
You can access notifications from the toolbar at the top-right section of Vault. Notifications include tasks, assignments, and updates.
Tab Views and Filters
The left pane on each Vault Safety tab contains Views and Filters that you can use to filter the tab to quickly locate records or documents. Certain Filters and Views come preconfigured in Vault Safety. You can also create custom Filters and Views. Vault Online Help provides information.