Managing Vault Clinical Basics Users

Admins have sole responsibility for user management in Vault Clinical Basics. These tasks can be subdivided into two categories: Setup and System Maintenance.

Before users can access your Vault, you must complete the following setup tasks:

Creating and Managing Users
Setting up Studies
Granting Study Access

In addition to the setup tasks, Admins also have responsibility for basic system maintenance:

Managing the Global Directory
Archiving Studies

Note: In order to create and manage users in the domain, you must have the Vault Admin Security Profile.

Vault has three user types:

Domain users: Typically employees within your company. These users may already be in your company domain.
Cross-domain users: Typically users from external organizations, such as vendors or inspectors. These users already have Veeva Vault credentials and will use them to access your Vault.
VeevaID users: VeevaID is an Identity Provider (IdP) system that allows you to use a single login for all Veeva applications. Users with a VeevaID can use their SSO credentials to access Vault.

Overview of Account Type, Security Profile, and Person Type

Account Types for Vault Clinical Basics: eTMF

Account Type	Permissions	Security Profile	Person Type
Vault Admin	All permissions of the Study Contributor, plus: User Accounts Management Study Data Management Reference Data Management This account has global access to all documents and data, and is not restricted by study.	Vault Admin	Internal
Study Contributor	All permissions of the Study Viewer, plus: Upload and Classify Documents Route Documents on Workflows	Study Contributor	Internal or Vendor (if CRO User)
Study Viewer	View Documents Log Quality Issues Participate in Workflows Run Reports and Dashboards	Study Viewer	Internal or Vendor (if CRO User)
External Inspector	View Approved Documents only Run select Reports	External Inspector	Vendor

Account Types for Vault Clinical Basics: CTMS

Account Type	Permissions	Security Profile	Person Type
CTMS Vault Admin	Combination of Vault Admin role plus Study Manager role permissions. This account has global access to all documents and data, and is not restricted by study.	CTMS Vault Admin	Internal
Study Manager	All permissions of the Monitor, plus: Study Creation and Management	Study Manager	Internal or Vendor (if CRO User)
Monitor	All permissions of the Study Contributor, plus: Monitoring Issue Management Subject Recruitment	Monitor	Internal or Vendor (if CRO User)
Study Contributor	All permissions of the Study Viewer, plus: Upload and Classify Documents Route Documents on Workflows	Study Contributor	Internal or Vendor (if CRO User)
Study Viewer	View Documents Log Quality Issues Participate in Workflows Run Reports and Dashboards	Study Viewer	Internal or Vendor (if CRO User)
External Inspector	View Approved Documents only Run select Reports	External Inspector	Vendor

Creating New Domain Users

Complete the following steps to create a new Domain user or add an existing Domain user to your Vault:

Open your Clinical Vault.
Navigate to Users > Create. The Create User page displays.
Click Domain User under User Details.
In the Domain User field, begin typing the user’s email address. A dropdown list displays:
- If the user is a part of your Domain, select them from the list.
- If the user is not a part of your Domain, click Create Domain User and enter their information in the pop-up window. Click Save. The system populates all known information in the General Info and Account Details sections.
Enter any contact information that has not been populated by the system.
The Grant User Access section includes a list of available profiles. Select the appropriate Security Profile for the user and enter it in the Account Details section.
Select the appropriate Person Type for the user.
Select the desired Activation Date.
Click the Send Welcome Email on Activation Date checkbox to ensure that the customer receives an email notification of their access.
Set the Security policy associated with the user:
- Basic (non-SSO)
- Required SSO
Click Save to save the user in the Vault.

Activating and Deactivating Users

Use Change State to set users to Active or Inactive in the System.