Add a user to a study in Oracle Clinical One Platform

A product administrator assigned to the Study Creator global role 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 study user administrator.

Note:

Study creators are the only users who can assign study users with roles for the study design mode. The user administrator permissions are associated to the study design. This means they are the only ones capable to add study user administrators. For more information, see Roles in user management.

After the user administrator is added to a study, either the global user (Study Creator or Global User Manager) can continue adding users, or the study user administrator can add the remaining users. Make sure you are added with the required permissions, either as a global user or a study user.

Before you can add a user to a study, the IAMS Customer Delegated Administrator (CDA) for your organization must create an Oracle Life Sciences SSO account for the user. For the general workflow, see Create study user accounts.

Caution:

Verify that the user took the relevant training assigned to their roles before starting to work, as your organization may have implemented mechanisms to track regulatory requirements for training. For more information, see Track training, and send training reminders.

1. From the Home page, Open the study's settings.
2. Navigate to the Users tab, and then select Add User.

   Note:

   You do not need to select a mode when adding a user.
3. Complete the fields on the Add User page using the details in the table below.

   Item	Description
   Full Name	Select the name of the user that you want to add to the study. Note: Only the users with an existing Oracle Life Sciences SSO account in the organization are available to be added to the study. If you cannot find a specific user, reach out to your organization's CDA or your Oracle point of contact.
   Username	This field is automatically populated with the selected user's user name and cannot be edited.
   Email	This field is automatically populated with the selected user's email address and cannot be edited.
   Effective Dates	Select a Start Date and an End Date, defining when the user can access the study. Or select No End Date to allow the user access without expiring. Tip: 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 and to retain a proper audit trail. 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 (or an hour earlier when observing daylight saving time).
   Study Roles	Select the appropriate study role for each mode. You are only required to select a role for one mode when adding a user. Refer to step 4 below to add the user to other modes after adding them to the study. Tip: Go to the Study Roles tab to see which permissions make up each role. For additional information, see Best practices for role, site, and depot assignment. Tip: Typically, users are assigned the same study role for both the training and production modes. If that is the case, select the Same as production mode option from the list when assigning the training role. Note: You should not assign template study roles. For more information, see Manage study roles.
   Sites	Select all of the sites the user needs access to for each mode. For more information, see Best practices for role, site, and depot assignment.
   Depots	This section only appears if depots are configured for your study. Select all of the depots the user needs access to for each mode. For more information, see Best practices for role, site, and depot assignment.

4. Select Add.

   The newly added user appears on the user table for those modes where a study role was selected. For example, if you selected a study role under Production and Testing, the user is added to those modes.

   To add the user to other modes, select a mode where the user was initially added, then edit the user to select study roles for the modes you want to add them to.

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.