Assessments Administration


Medical monitors and other users in similar roles can perform clinical assessments from within Vault EDC. Before a user can perform a clinical assessment, you must first assign a Study Role to that Assessment from EDC Tools > Assessments.

This feature is only available in vaults where Role by Study is enabled. If Role by Study is not enabled in your vault, contact your Veeva Services representative.

Viewing Assessments

Once you navigate to EDC Tools > Assessments, Vault displays a list of all existing Assessment Definitions in your study. You can filter this list by Type (from Assessment Type) or search for a specific Assessment. Before any Assessments display in this listing, a study designer must create them in Studio.

Assigning Assessments

You can assign each Assessment Definition to a Study Role. Users with this Study Role are able to view and perform any Assessments of that definition. For example, you may assign a Serious Adverse Event assessment to users with a custom SAE Assessment Editor role. Veeva has certain recommendations for managing Study Roles with assessments. See details below.

To assign an Assessment:

  1. Navigate to EDC Tools > Assessments.
  2. Locate the Assessment that you want to assign a role to in the listing.
  3. Hover over that Assessment to display the Actions menu.
  4. From the Actions menu, select Assign Roles. Vault opens the Assign Study Roles to Assessment dialog. Assign Roles action

  5. In the Assign Study Roles to Assessment dialog, search or scroll to locate the roles you want to assign to an Assessment. Search Study Roles

  6. Use the Arrow buttons or double-click on Study Roles to move them from the Available Roles column to the Assigned Roles column. Move roles to the Assigned Roles column

  7. When finished, click Save. Vault assigns the Assessment to the Study Roles in the Assigned Roles column.

Role Management for Assessments

Veeva recommends that you use the standard CDMS Clinical Assessment Reader and CDMS Clinical Assessment Editor study roles as templates to create custom Study Roles associated with each of your Assessment Definitions. For example, if you have a Serious Adverse Event Assessment, create an SAE Assessment Reader and an SAE Assessment Editor role for that assessment.

Learn more about creating custom Study Roles here.

Users with the CDMS Lead Data Manager study role can perform the actions described above by default. If your vault uses custom Study Roles, your role must provide the following permissions:

Type Permission Label Controls
Functional Permission EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Assessments

Ability to assign Study Roles to Assessment Definitions from EDC Tools > Assessments

Learn more about Study Roles.