Add a user to a study in Oracle Clinical One Platform

A product administrator who was created as a global user adds the first user to a study and assigns study roles. The first user in a study is typically an administrator who is responsible for adding other users to the study. This user is called a user and site administrator.After the user and site administrator is added to a study, the global user can continue adding users, or the user and site administrator can add the remaining users.

Before you can add a user to a study, you must:

• Create an account for the user as described in Create an Oracle Life Sciences single sign-on.
• Check that your account includes the Global User Manager or Study Creator role as described in Assign roles in Oracle Life Sciences IAMS.
• Verify that the user took the relevant training assigned to their roles before starting to work. Your organization implements mechanisms that address regulatory requirements for training.
• Sign in to Oracle Clinical One. For details, see Sign in and out of Oracle Clinical One Platform.

To add a user to a study in Oracle Clinical One Platform:

1. On the Home page, click Study Settings () , then select Open Settings.
2. Select the Users tab, and then click Create/Assign User.
   The Create/Assign User window opens.
3. Click Assign a User and complete the following fields.

   Item	Description
   Full Name	Select the name of the user that you want to add to the study.
   User Name	This field is automatically populated and cannot be edited.
   Email	This field is automatically populated and cannot be edited.
   Effective Date Range	Enter a From and To date, defining when the user can access the study. Note: Oracle Clinical One Platform uses Coordinated Universal Time (UTC) to determine study access. For example, a user with an effective from date of 03 Apr can access the study as of 12:01 AM UTC on the 3rd. If the user is on the United States East Coast, they can access the study at 8:01 PM ET on the 2nd. It would be an hour earlier when observing daylight saving time. Select No End Date to allow the user access without expiring. However, we recommend specifying an end date to ensure you can record when a user had access to the study after it ends. Specifying an end date is also recommended in place of removing a user, making it easier to reinstate a user if needed.

4. Select the appropriate Study Roles for each mode, then click Next. For a list of permissions assigned to each study role, click View Permissions for Study Roles, then select the role to see the permissions.

   Item	Description
   Study Design Mode	Select a study role if the user needs to be part of the study design process.
   Testing Mode	Select a study role if the user needs to be included in testing before the study goes live.
   Production Mode	Select a study role if the user needs to access the study during the study conduct period.
   Training Mode	Select a study role if the user needs to complete training. Note: Users typically have the same study role in training and production modes. If that is the case, click Same as production mode.

5. Select the sites and depots the user needs access to. For more details, see Best practices for role, site, and depot assignment.

   Note:

   You can select All Sites and All Depots or you can select individual sites and depots.
6. Click Finish.
   You are presented with the system message, Success, The <user name> user has been created.

The user receives an email with the name of the study, the URL for Oracle Clinical One Platform, and the date when they can start working.