User Access & Sharing

Once you have designed your study, you can share it with other users by assigning appropriate User Types and User Roles. These determine what each user can see and do within the Study Build System and study environments (Test and Production).

User Types

Each user is assigned a User Type and a User Role.

There are two User Types in OpenClinica:

User Type defines global permissions—what tasks a user can perform across all studies. For example, only Admins can create studies or access the Administration page.

User Role determines study-level access and specific tasks the user can perform based on the assigned User Type in the Test or Production environments.

For example,

• A user might have User Type:Admin and User Role:Data Manager
• Another user might have User Type: User and User Role: Investigator

? Best Practice

The Admin User Type should be assigned sparingly because administrators have access to all studies. Most users should be assigned the User Type of User. Site users should never be assigned a User Type of Admin, as this would give them potential access to all data across all studies and sites in your Test and Production environments.

Each user can have only one User Type, but can hold different User Roles in different studies or sites.
Example: A user may have the User type, with the Data Manager role in one study and Study Monitor in another.

User Roles and Permissions

User Roles define what actions users can perform within a study or site.

ℹ️ Note: Site-level users can only see Participants at the sites they are assigned to. They cannot see study-level Participants. Study-level users can see all Participants.

Form-related permissions — such as viewing, entering, editing, clearing data, and managing queries — are configurable for each form via Form Access Settings (Read Only, Review, Edit).

Participants

Events

Forms

Queries

⚙️ Form actions depend on Form Access settings (Read Only, Review, or Edit). For more information, refer to Managing Form Access and Permissions.

Verification & Data Extract

Study Management (when “Manage Study” is enabled)

Data Manager only can:

• Edit Study Settings
• Edit Study Design
• Publish Study
• Add Sites
• Invite Users

For more information on permissions available to each of the OC4 User Roles, refer to User Matrix (PDF).

Accessing the User Roles Screen

1. From the My Studies screen, click the Settings icon on the Study Card.
2. Select User Roles.

The Role column displays the name of the role in bold, and the role it was based in in parenthesis.

The Access column displays:

You can update these while creating or editing a user role.

Training Requirements Column

The Training Requirements column appears between the Access and Actions columns on the User Roles screen.

This column displays training requirements configured for the role.

• If Core Training Required is selected for the role, the column displays Core.
• If Core Training Required is not selected, the column remains blank.

You can update these while creating or editing a user role. For more information on Trainings, refer to LMS Integration LMS Integration.

Create a New User Role

1. On the User Roles screen, click the Create button.
2. In the Create New Rolewindow, complete the following fields:
   1. Enter a Name for the new User Role.
   2. Select a standard User Role to base the new User Role on. (The base User Role provides core permissions of the custom User Role.)
   3. Enter a description for the User Role. (The default User Role description appears to the right/below the User Role in the Based On field.)
   4. Assign Permissions as needed
   5. (Optional) Select the Core Training Required checkbox to require users assigned to this role to complete Core Training.
      ℹ️ Note: If not selected, no training requirement is configured for the role.
3. Click Save.

ℹ️ Note: Once saved, a User Role is available in both Test and Production environments for the current study.

Edit a User Role

1. On the User Roles screen, click the Edit button to the right of the role you want to edit.
2. Update one or more of the following fields as needed:
   • Name
   • Based On
   • Description
   • Permissions
   • Training Requirements
3. Click Save.

ℹ️ Important Considerations

• User Roles are defined per study.
• Custom User Roles have the same access as the User Roles they were based on by default. Specific permissions can be updated as defined above.
• Both Base User Roles and Custom User Roles can be edited.
• Permission updates take effect immediately after saving; republishing the study is not required.
• Changes to roles assigned to users, user role definitions, and permissions assigned to user roles take effect for users based on whether they are logged in at the time of the change.
  • Users not logged in will see updates upon their next login.
  • For users who are logged in at the time the change was made, the change will be active in their session when they do any of the following:
    • Clicking Go from Study Designer
    • Accessing Change Study in Study Runner
    • Navigate to any other Study Runner page (may not take effect for up to five minutes from when the change was saved)
    • Log Out and Log In
• Permissions sections within the Create and Edit Role screens are collapsible.
• All roles roles default to Core Training Required unchecked.
• If you need a user to have access in one environment but not another, assign a different User Role in each environment.
  For example,
  A user may be assigned Clinical Research Coordinator 1 in the Test environment and Clinical Research Coordinator 2 in the Production environment.
  In this setup, Clinical Research Coordinator 1 in Test environment might have access to a specific form, while Clinical Research Coordinator 2 in Production environment does not—depending on the permission tags applied to that form.