You can track, manage, and report on quality issues in your Vault using a document lifecycle state user action and the Quality Issue object.
The Quality Issue object is a standard Vault object that allows you to create and assign issues and quality checks, track who is responsible for fixing specific issues, and report on the number of open issues in your Vault, among many other valuable applications.
Note: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults. Some configuration by an Admin is required before you can start logging Quality Issues for documents.
Creating Quality Issues
Imagine for a moment that, upon reviewing a document in your Vault, you realize there are inconsistencies with a document that Joe is responsible for. You would like Joe to resolve this issue, so you decide to create a Quality Issue.
Note: You should only use Quality Issues for Classified documents. Using Quality Issues for Unclassified documents may cause Issue Count fields to be out of sync.
- From the document’s Actions menu, select Log Quality Issue.
- In the dialog, choose the user to assign this task to. You can select any user that has a role on the document. In this case, you select Joe.
Note: Only users with View permission for the document appear in the Assigned To dialog.
- Select the QC Issue Type and enter QC Issue Comments.
- Optional: If you create a Quality Issue from the object records page, you will need to manually select the Related Document. A Quality Issue can only have a single Related Document, but a document can have multiple Quality Issues.
- If study and blinding security is enabled in your Vault, Vault defaults the Study and Content fields to the corresponding fields on the document. If the document has multiple Study field values, you must select one.
- Click Save.
Note: Depending on your Vault’s configuration, the Content document field may be labeled Blinding.
Upon saving, Vault automatically assigns Joe a Quality Issue Task to fix the issue, sends him an email notification, and populates the following fields on the Quality Issue object record:
- Quality Issue ID: The ID of the Quality Issue (QI-{#####})
- Due Date: Defaulted to the created date plus 28 days. An Admin can change this number when they configure Quality Issues.
- Number of Days Open
- Days until Due
You can view all Quality Issues, open or closed, for a particular study from the TMF Homepage.
Resolving Quality Issue Tasks
As with other tasks, Joe sees the newly created Quality Issue in Home > My Tasks. Joe can click on the task to view the related document, issue type, and issue comments. He can also re-assign the task using the Reassign action on the task in the Workflow Timeline.
Once Joe decides how to handle the issue, it’s time for him to close it. Joe navigates back to My Tasks and clicks Complete for the Quality Issue. He can also do this from the Quality Issue object record.
At this point, Vault prompts Joe to provide a verdict for the issue: Resolved, Unresolved, or Non-Issue. Vault requires a reason for the Unresolved and Non-issue verdict.