Medical monitors and other users in similar roles can perform medical assessments from within Vault EDC. Users can quickly enter assessment data and view related, supplemental data from a single location. Vault dynamically creates assessments as related Subject data is entered into the system, so the list of open assessments is always up to date.
Vault adds new Assessments only after a data entry user (such as a principal investigator or clinical research coordinator) completes a Form to trigger assessment creation, based on the study’s design.
For an SAE (serious adverse event) assessment, Vault may create an Assessment after a user completes a Form with the Seriousness item set to Yes.
But after the Assessment gets added and is viewable to Vault Owners, users in the proper Study Role (such as a CDMS Clinical Assessment Reader or CDMS Clinical Assessment Editor) are still not able to see the Assessment. Why does this happen?
The Assessment definition is not assigned to the user's Study Role.
Admin(normally Lead Data Manager) 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.
To assign an Assessment:
- Navigate to Tools --> EDC Tools --> Assessments for the Study.
- Locate the Assessment that needs to assign a role to in the listing.
- Hover over that Assessment to display the Actions menu.
- From the Actions menu, select Assign Roles.
- In the Assign Study Roles to Assessment dialog, search or scroll to locate the roles needed to assign to an Assessment.
- Use the Arrow buttons or double-click on Study Roles to move them from the Available Roles column to the Assigned Roles column.
- When finished, click Save. Vault assigns the Assessment to the Study Roles in the Assigned Roles column.
Vault Help Documentation: Assessments Administration