Invite Users

Anyone with a user role of Data Manager can create and invite users to access his/her study(ies). As part of the invitation process, the Data Manager specifies what each user can have access to based on that user’s type and user role. For more information, see User Type.

When the user receives and accepts the email invitation, s/he is prompted to set a password:

Password requirements are as follows:

  • Must be at least 8 characters in length
  • Must contain at least three of the following types of characters:
    • Lower case letters (a-z)
    • Upper case letters (A-Z)
    • Numbers (0-9)
    • Special characters (!@#$%^&*)
  • Cannot be the same as the previous password
  • Cannot be one of the most common 10,000 passwords (e.g., password, 12345678, asdfasdf, etc.)
  • Cannot contain any part of the user’s personal data (e.g., first name, last name, username, email address)

In addition:

  • User accounts are locked after ten failed login attempts from the same IP address.
    • To unlock the account contact support@openclinica.com
  • Users are automatically logged out of OpenClinica after four hours of inactivity.

User Type

When a user is created, that user is assigned a user type and a user role.

  • User type determines the user’s access level. For example, it defines whether the user can access data across all studies and sites (Admin), or only to specifically assigned studies or sites (User).
  • User role determines the specific tasks the user can perform within that realm of the assigned user type.

Available user types are:

  • Admin
    • Can create studies and can see all studies that exist in your test and production environments.
    • Can assign him/her-self access to any study in your test and production environments.
  • User
    • Can only view and access studies or sites assigned to the user account.

When assigning a user type, keep the following in mind:

  • Because Administrators have overall access to all studies, this user type should be assigned sparingly. Most users should be assigned the user type of “user.”
  • Site users should never be assigned a user type of Administrator – this would give them potential access to all data across all studies and sites in your test and production environments.

  • Each user only has only one user type, but may have different user roles in different studies or sites. 

    For example, you may be a user type of “user,” with a role of Data Manager on one study and a role of Monitor on another study. 

Refer to the User Matrix for a table of permissions available to each of the OC4 user roles.

User Profile

All users have access to updating their user profile and password at any time.

From the User Menu, selecet My Profile:

To edit your user information, click the Details edit link and update your information as needed:

Note that you cannot change the email address associated with your account. Please contact your Administrator if you need to change your email address.

To change your password, click the Change password link and update your password:

Users also have access to OpenClinica Support and to the OpenClinica Privacy Policy from the user menu:

  • To access the OpenClinica Support Team (contract-based, named users, only), from the User Menu, select Support:

    And the support portal displays:

  • To access OpenClinica’s Privacy Policy, from the User Menu, select the Privacy Policy:

And you are directed to the Privacy Policy page of the OpenClinica website.

Study-Specific User Administration

Data Managers can manage user accounts for studies to which they have access. To manage users for a study, go to My Studies and click the Share button for the study for which you want to manage users:

You can then invite, edit, or remove users as needed. You can also resend an invitation if the user has accidentally deleted the original invitation. Changes made on this page only apply to the current study.

Central User Administration

Administrators have access to Central User Administration, where user accounts can be edited, deactivated, or re-activated across all environments. Administrators can also download the User and Role Audit Logs, which lists login attempts, role changes, profile changes, role changes, password reset requests, and more. To access Central User Administration, from the User Menu, select Administration (only Administrators have access to this menu option):

In the Administration window, Deactivate or Edit user accounts as needed. Changes made in this window apply to the user account across all studies and environments.

If a user account is deactivated, that user cannot log into OpenClinica.