Table of Contents

• Title and Copyright Information
• Preface
  • Audience
  • Documentation accessibility
  • Diversity and Inclusion
  • Related resources
  • Access to Oracle Support
  • Additional copyright information
• 1 Account basics
  • Difference between access to Oracle products and access to clinical studies
  • Roles in user management
  • Tasks that Oracle completes for you
  • Types of single sign-on accounts
  • About Oracle Life Sciences Identity and Access Management Service (IAMS)
  • Notifications for Oracle Life Sciences SSO account activation
    • Activate your account when you receive one notification message
    • Activate your account when you receive two notification messages
  • Sign in to Oracle Life Sciences IAMS
    • Bookmark and sign in directly to Oracle Life Sciences IAMS
    • Sign in through Oracle Health Sciences My Oracle Bookmarks
    • Sign in through the Oracle Health Sciences Cloud home page
• 2 Account creation prerequisites
  • Prerequisites to create accounts
  • About the approval process
  • Specify a password for Support Cloud
  • Request the creation of the Approver role
  • Create user account for the Approver
  • Activate approval for roles
  • Publish the roles
  • Set up an authorization request page
• 3 Create user accounts
  • Create an Oracle Life Sciences Single Sign-On (SSO)
  • Assign roles in Oracle Life Sciences IAMS
  • Roles in Oracle Life Sciences IAMS for all applications
  • Create and manage Oracle Life Sciences Single Sign-Ons (SSO) in bulk
    • Download a bulk import sample file
    • Update the bulk import file
    • Guidelines for updating the bulk import file
    • Commands available to include in a bulk import file
    • Import a file for bulk updates
    • Download a file from a previous bulk import
  • Create accounts for different types of users with access to specific products
    • Create product administrator accounts
    • Create study user accounts
    • Provide user access to Oracle Clinical One Digital Gateway
• 4 Manage Oracle Life Sciences Single Sign-On (SSO) accounts
  • Recover your Oracle Life Sciences single sign-on user name
  • Unlock a locked account
  • Change your password
  • Change your challenge questions
  • Update your name or telephone number
  • View roles assigned to you
  • Request product roles
  • Manage access requests
    • Review and approve an access request
    • Customize your view of access requests
• 5 Manage users and roles in Oracle Clinical One Platform
  • Access Oracle Clinical One Platform
    • Identify the Oracle Clinical One Platform web address for your organization
    • Sign in and out of Oracle Clinical One Platform
  • Add a global user in Oracle Clinical One Platform
  • Add a global role to an existing global user
  • Roles for global users in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway
  • Remove a global user in Oracle Clinical One Platform
  • Add a user to a study in Oracle Clinical One Platform
  • Edit a single study user
  • Edit multiple study users
  • Add and edit multiple study users using templates
    • Guidelines for using templates
    • Add or edit multiple study users
  • Delete a study user
  • Manage study roles
    • Create a study role at the global level
    • Create a study role at the study level
    • Edit a study role
    • Specify data classifications for a study role
    • Retire a study role
  • Types of study roles in Oracle Clinical One Platform
    • Roles for Study Design mode
    • Roles for blinded study team users
    • Roles for unblinded study team users
    • Roles for site users
  • Best practices for role, site, and depot assignment
    • Assignments for user administrators
    • Assignments for study team members
    • Assginments for site and depot users
  • Run and download report
• 6 Template study roles
  • About template study roles
  • Adjudicator
  • Blinded Depot User
  • Clinical Research Associate (CRA)
  • Clinical Supply Manager - Unblinded
  • Data Manager
  • Medical Monitor
  • ODM Extract
  • Pharmacy User - Unblinded
  • Production Admin
  • Rules Designer
  • Site Administrator
  • Site User
  • Statistician - Unblinded
  • Study Designer
  • Study Manager
  • Unblinded Depot User
  • User Administrator
  • View Only for Unblinded Support Users
  • View Study Design
• 7 Descriptions of permissions in Oracle Clinical One Platform
  • Sponsor and Site permissions
    • Administrative
    • CRF Submit Access
    • Clinical Data Collection
    • Data Extract
    • Inventory Management
    • Notifications
    • Reports
    • Rules Management
    • Settings
    • Study Management
    • Study Setup
    • Trial Management
    • Unblinded Study Management
  • Design permissions
    • Reports
    • Study Design
• 8 Learn: Frequently asked questions
  • Can I update a user's Oracle Life Sciences single sign-on?
  • Do I need to revoke access for SaaS Services users after collaboration is complete?
  • Do I need to revoke access for Life Sciences Support users after a ticket is resolved?
  • How do I control users' access to the application?
  • What happens if I change the roles assigned to a user while the user works in the product?
  • Does my organization need a user and site administrator?
  • Can I create Oracle Life Sciences single sign-ons in Oracle InForm User Management Tool?
  • Who creates Oracle team members?
  • How do I find my company's ShortOrgId?
  • What should I do if I have a study that requires users to screen subjects and enter data before and after randomization, but not randomize them?
• 9 Revision history