Note Beginning with 24R1 in April 2024 and for all subsequent releases, Vault Safety General Release Help content is moving to a new site. Test the new site using Limited Release content.
For the latest information about these features, refer to Vault Safety Help. Learn More links to specific Help articles are included below each video.
Note In 21R2, Vault has a redesigned user interface (UI). As a result, unless you opted out of the new UI, the videos on this page may not match the user interface in your Vault.
Getting Started with Vault Safety
Use Vault Safety Tabs
Learn how to navigate Vault Safety tabs.
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Use Views, Search Bar, and Filters
Learn how to use views, the search bar, and filters in Vault Safety.
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Intake
Creating an Inbox Item Manually
Learn how to create an Inbox Item manually in Vault Safety.
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Creating an Inbox Item via Email
Learn how to create a manual Inbox Item from an email source document in Vault Safety.
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Create AER from Source Document
Learn how to intake an AER from a source document, such as an E2B file, in Vault Safety.
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AER Intake and Data Entry
Learn how to perform AER intake and data entry in Vault Safety.
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- Create an Adverse Event Report Manually
- Case Intake Overview
- AER Field Reference
- Inbox Item Transition From AERs
Promote to Case
When you promote an Inbox Item or AER to a Case, Vault Safety duplicate detection compares the current record against all other Cases in the system. Watch these three videos to learn about the following:
- How duplicate detection supports creating new and identifying duplicate Cases.
- How to create follow-up Cases or merge a follow-up report into an in-flight Case.
- How to copy patient information from an existing Case to a new Case.
Duplicate Case Detection
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Working with Follow-Up Information
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Copying Patient Information from an Existing Case
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Case Processing
Case Narrative Generation
Learn how case narratives are generated.
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Managing Action Items
Learn how to assign and manage action items, such as requests for case follow-up information.
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Using the Medical Review Timeline
Learn how to use the Medical Review Timeline, an interactive tool for viewing Case events.
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Manually Generate Regulatory Report Forms
Learn how to manually generate the MedWatch FDA 3500A form or the CIOMS I form.
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Datasheets and Auto-Expectedness Evaluations
Vault Safety calculates whether an adverse event is expected and listed on product labels and investigator brochures. Watch these videos to learn about the following:
- Setting Up Core Datasheets
- Setting Up Local Datasheets
- Understanding Expectedness Evaluations
- Understanding Precise Expectedness Evaluations
- Overriding Auto-Expectedness Evaluations
Setting Up Core Datasheets
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Setting Up Local Datasheets
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Understanding Expectedness Evaluations
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- How Expectedness is Used in Safety Features
- Enter Case Data: Expectedness Section
- Case Assessment Expectedness Generation
Understanding Precise Expectedness Evaluations
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Overriding Auto-Expectedness Evaluations
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Managing Reports and Dashboards
Create Reports
Learn how to create reports on cases, documents, workflows, and other data.
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How to Use Case or Transmission Unique Numbers in Reporting
Learn how to set up custom periodic or aggregate reports using the Case or Transmission Unique Number field to retrieve the latest versions.
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Create Dashboards
Learn how to create dashboards to visualize reports and data.
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Administration
Use Study Arms
Learn how to set up and use Study Arms.
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Deploy Vault Safety Self-Serve Pre-Release Sandbox Vaults
Learn about the pre-release period and how to deploy self-serve pre-release vaults.
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