Clinical Basics Users

Before users can access your Vault, you must complete the following setup tasks and those tasks are shared between technical Vault Admins and business-focused TMF Managers:

  • Create and Manage Users (Vault Admin)
  • Set up Studies (TMF Manager)
  • Grant Study Access (TMF Manager)

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

  • Manage the Global Directory
  • Archive Studies

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 Veeva Clinical Basics: eTMF

Account TypePermissionsSecurity ProfilePerson Type
Vault AdminAll permissions of the Study Contributor, plus:
  • User Accounts Management
  • Study Data Management
  • Reference Data Management
  • Vault Loader
This account has global access to all documents and data, and is not restricted by study.
Vault AdminInternal
TMF ManagerAll permissions of the Study Contributor, plus:
  • Study Data Management
  • Reference Data Management
TMF ManagerInternal
Study ContributorAll permissions of the Study Viewer, plus:
  • Upload and Classify Documents
  • Route Documents on Workflows
Study ContributorInternal or Vendor (if CRO User)
Study Viewer
  • View Documents
  • Log Quality Issues
  • Participate in Workflows
  • Run Reports and Dashboards
Study ViewerInternal or Vendor (if CRO User)
External Inspector
  • View Approved Documents only
  • Run select Reports
External InspectorVendor

Account Types for Veeva Clinical Basics: CTMS

Account TypePermissionsSecurity ProfilePerson Type
Vault AdminCombination 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.
Vault AdminInternal
Study ManagerAll permissions of the Monitor, plus:
  • Study Creation and Management
Study ManagerInternal or Vendor (if CRO User)
MonitorAll permissions of the Study Contributor, plus:
  • Monitoring
  • Issue Management
  • Subject Recruitment
MonitorInternal or Vendor (if CRO User)
TMF ManagerAll permissions of the Study Contributor, plus:
  • Study Data Management
  • Reference Data Management
TMF ManagerInternal
Study ContributorAll permissions of the Study Viewer, plus:
  • Upload and Classify Documents
  • Route Documents on Workflows
Study ContributorInternal or Vendor (if CRO User)
Study Viewer
  • View Documents
  • Log Quality Issues
  • Participate in Workflows
  • Run Reports and Dashboards
Study ViewerInternal or Vendor (if CRO User)
External Inspector
  • View Approved Documents only
  • Run select Reports
External InspectorVendor