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 Health Sciences single sign-on.
- Check that your account includes the Global User Manager or Study Creator role as described in Assign roles in Oracle Health 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.
Show me how!
To add a user to a study in Oracle Clinical One Platform:
- On the Home page, click Study Settings () , then select Open Settings.
- Below the study name, click the Users tab.
- Click Create/Assign User.The Create/Assign User window opens.
- Click Assign a User.
- From the User Name field, select the user to be assigned to the study.The First Name, Last Name, and Email fields automatically populate.
- For Effective Date Range, enter a
From date, defining when the user can first access
the study and a To date, defining when access to the
study will end. If an end date has been defined, the user's access will expire
at 11:59 PM UTC on that date.
Note:To allow the user access without expiring, select No End Date. We recommend specifying the end date for a user, so you can have a record of when the 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.
- Select the appropriate Study Roles for each mode, then click Next.
Option Description Study Design Mode If the team member you want to add to the study should also be part of the study design process, choose a role for this mode. Testing Mode Choose a study role for this mode if the team member needs to test the study before going live. Production Mode Choose a study role for this mode if the team member needs to work during the study conduct period. Training Mode Choose a study role for this mode if the team member needs to assign or complete training. Users typically have the same roles for both Training and Production mode, so in most cases you can click the Same as production mode checkbox.
- Select the sites and depots for the user according to their roles. 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.
- 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.