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. 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. Veeva Safety is built on the Veeva Vault Platform and shares the same configuration concepts.
Standard Object Layouts
To utilize a new or updated feature, ensure your Vault uses the current layouts for all related objects. We recommend copying the latest standard layouts to ensure they include all required fields:
- Copy the standard layout and ensure it is active.
- Set the new custom layout as the default.
- Delete any other existing custom layouts.
About Safety System Settings
Authorized Admin users can view Safety System Settings on the Business Admin tab. These records are informational only to show which settings are enabled and cannot be modified in your Vault. Contact your Veeva Representative for more information.
Connections
Create integrations locally, between Vaults, or with an external application. The following articles provide additional information:
- AS2 Connection
- Clinical Data to Safety E2BLink Connection
- Medical-Safety Connection
- Quality-Safety Connection
- Safety-Clinical Operations Connection
- Safety-EDC Connection
- Safety-RIM Connection
About Default Case Naming Conventions
When you create a Case, Vault generates a descriptive record name to enable you to quickly browse and identify records. Vault updates Case Name values when details on the Case change, including the Watchlist tag, primary product or combination product, primary Adverse Event (AE), or country.
Note: Do not modify the Case Name naming convention.
Naming Conventions for Imported Cases
When you import from E2B files, Vault assigns a Case name that matches its unique identifier (UID) and populates the Case Number based on the source file. For example: US-VC-000011. 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 maps descriptive names for Case Assessments, Products, and Adverse Events from the related product and adverse event name fields. 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:
- 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, we recommended using Product (Coded) and Blinded Names for analytic reports rather than the Vault-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
For names that exceed 128 characters, Vault reserves 100 characters for Product name and the remaining 28 characters for separators and Adverse Event name. Additional characters are 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.