Vault Safety comes with various default configurations, including a set of fields, document types, lifecycles, and workflows. You can use your Vault immediately with the default configuration settings. Simply follow the appropriate steps to set up your Vault when you first get started:
- First Steps for Safety Admins
- First Steps for Safety Workbench Admins
- First Steps for Safety Signal Admins
- First Steps for SafetyDocs Admins
You can also customize your Vault to match your company’s unique processes. Vault Safety is built on the Vault Platform and shares the same configuration concepts. Administering Vault provides information on general Vault Platform administration.
Connections
Create integrations locally, between Vaults, or with an external application. See Creating & Managing Connections for more information.
The following articles contain help for configuring connections between Vault Safety and other Veeva Vaults:
| Connection | Help Article |
|---|---|
| Safety-EDC Vault Connection |
About the Safety-EDC Vault Connection |
| CDMS to Safety E2BLink Connection | Configuring E2BLink |
| Safety-Clinical Operations Vault Connection |
About the Safety-Clinical Operations Vault Connection Configuring the Safety-Clinical Operations Vault Connection Enable the Safety-Clinical Operations Vault Connection: Safety Letters |
| Medical-Safety Vault Connection |
About the Medical-Safety Vault Connection |
| Safety-RIM Vault Connection |
About the Safety-RIM Vault Connection |
| AS2 Connection | Configure Custom AS2 Connections |
About Safety System Settings
Safety System Settings is a component on the Business Admin tab. Only authorized users have access to view Safety System Settings.
This page is informational only to show which settings are enabled. Safety System Settings cannot be edited directly in Vault Safety. If you require settings which are not enabled in your Vault, contact Veeva Support or your Veeva Services representative.
About Default Case Object Naming Conventions
After you create a Case, Vault generates a descriptive Case name to enable you to quickly browse and identify Cases. See About System-Managed Object Record Names for more information. Case names are updated when details on the Case change, including the Watchlist tag, primary Product or Combination Product, primary Adverse Event, or country.
Note: Do not modify the Case object naming convention. In particular, do not modify the Case Name.
Naming Conventions for Imported Cases
When you import a Case from an E2B file, the Case name will match its unique identifier (UID). The Case Number will also populate from the E2B source file.
For example: US-VC-000011
Note: Vault does not update imported Case names.
Naming Conventions for Clinical Study Cases
When the adverse event is associated with a Study Product, the naming convention depends on whether the Study is blinded.
Blinded Study
Vault names blinded study Cases in the following format:
{Case Number} (v{Version}) - {Case Tag} - ●●●●●/{Study Number} - {Primary Adverse Event MedDRA} - {Country Code}
For example: 00001 (v.01) - SAE - ●●●●●/ABC-1234-D - Heart Attack - US
Open Study
Vault names open study Cases in the following format:
{Case Number} (v{Version}) - {Case Tag} - {Product Name}/{Study Number} - {Primary Adverse Event MedDRA} - {Country Code}
For example: 00002 (v.01) - SUSAR - Cholecap/ABC-1234-D - Heart Attack - US
Naming Conventions for Non-Study Cases
Vault names non-study Cases in the following format:
{Case Number} (v{Version}) - {Case Tag} - {Product Name} - {Primary Adverse Event MedDRA} - {Country Code}
For example: 00003 (v0.1) - SAE - Cholecap - Heart Attack - US
Naming Conventions for Case Child Records
Vault Safety maps descriptive names for Case Assessments, Products, and Adverse Events from the related product and adverse event name fields.
Note: Names that exceed 128 characters are truncated, identified by an ellipsis (…).
Case Product Name
The way that Vault generates Case Product names depends on the Report Type and blinding settings.
The following list describes the Case Product naming conditions:
- For Study Cases with blinded Study Products, Vault uses the Blinded Name (
study_product_placeholder__v) if available. For example, Cholecap vs. Placebo - For all other cases, Vault uses the name of the Product (Coded) (
product_name__v) or Product (Reported) (product_reported__v) if available. For example, Cholecap - If the required field is unavailable, Vault uses the default
VV-{####}naming convention.
Note: For Product Names that exceed 128 characters, you are recommended to continue using Product (Coded) and Blinded Names for analytic reports rather than the system-generated Case Product Names, as those are the untruncated representations that appear in generated forms.
Case Adverse Event Name
Vault names Case Adverse Events using the name entered in the Event (LLT) (event_meddra__v) or Event (Reported) (event_reported__v) fields.
For example: Fever
Case Assessment Name
Vault names Case Assessments in the following format:
{case_product__v.name__v} ⇄ {case_adverse_event__v.name__v}
For example: Cholecap ⇄ Fever
Note: For names that exceed 128 characters, Vault will reserve 100 characters for Product name and the remaining 28 characters for separators and Adverse Event name. Additional characters will be truncated, identified by an ellipsis (…).
Case Attachment Document Naming Conventions
Do not modify the naming conventions for Case > Source > Literature or Case > Source > Attachments document types, as Vault relies on the naming for both generating and importing attachments in E2B files.