Edit a study role that is already assigned to users

As a global user manager or study user administrator, you can edit an existing study role created for both all studies or just an individual study, even if the study role is already assigned to users.

You cannot edit a predefined study role template provided by Oracle. Those study roles are read-only. To recognize them in the user interface, look for the icon containing a lock (Predefined study role icon).

Note:

For study-level roles, the changes that you make are automatically reflected in the already-assigned study roles. For organization-level roles, the changes that you make will apply to newly created studies but won't automatically propagate to existing studies.

To edit a study role that is already assigned to users:

  1. On the Home page, click the study settings button (settings button) on the study you want to edit and select Open Settings.
  2. Below the study name, click the Study Roles tab.
  3. Select an existing study role from the list (that was created for a single study only), and go to the Permissions pane on the right.
  4. Make any desired changes to the following fields:
    • Role Name: Enter a name for the study role. We recommend using a descriptive name so you'll remember the roles that are in the template later.
    • Type: Select Sponsor if the role will be assigned to a member of the study team at either the sponsor or CRO, Site if the role will be assigned to a site user, or Design if the role will be assigned to a study designer.
    • Description: This is optional, but you can add a short description of the study role in this field.
  5. Select or deselect the permissions that you want to include in this study role.

    Note:

    The search is performed across all three groups of rights: sponsor, site, and design. Changes to the study role at the study level are applied to users that already have this study role assigned to them. Pay attention to the soft warning messages in the product for when you are about to add a permission that does not typically belong in the study role. You must be careful to not add any unblinding permissions without considering the consequence of unblinding the wrong user.
  6. Click Apply Changes.

Figure 4-3 How a global user manager or user manager edits a study role assigned to users

A study role is a collection of permissions