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:

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. Administering Vault provides information on general Platform Vault 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 Safety Vaults and other Veeva Vaults:

Connection Help Article
AS2 Connection Configure Custom AS2 Connections
Clinical Data to Safety E2BLink Connection Configuring Safety Link
Medical-Safety Connection

About the Medical-Safety Connection

Configuring the Medical-Safety Connection

Enable the Medical-Safety Connection

Quality-Safety Connection

About the Quality-Safety Connection

Configuring the Quality-Safety Connection

Safety-Clinical Operations Connection

About the Safety-Clinical Operations Connection

Configuring the Safety-Clinical Operations Connection

Enable the Safety-Clinical Operations Connection: Safety Letters

Safety-EDC Connection

About the Safety-EDC Connection

Configuring the Safety-EDC Connection

Enable the Safety-EDC Connection

Safety-RIM Connection

About the Safety-RIM Connection

Configuring the Safety-RIM Connection

Enable the Safety-RIM Connection

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 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.

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

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.

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.

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

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.