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 create and track Quality Issues on the most recent versions of Classified documents. Using Quality Issues for Unclassified documents may cause Issue Count fields to be out of sync.
To create a Quality Issue:
- From the document’s Actions menu, select Log Quality Issue.
- In the dialog, select a user for the Assigned To field. Note that the Assigned To field defaults to the document owner, and the drop-down menu for the field lists only users with at least view permission and a role on the document when an Admin configures the Securing Assigned To application control field. In this case, you select Joe.
- Select the QC Issue Type and enter QC Issue Comments.
- Optional: If you create a Quality Issue from the object records page, 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.
Creating Self-Evident Corrections (SECs)
Self-Evident Corrections allow Quality Control (QC) Specialists to correct specific errors on documents while also having Vault track the occurrence of these Quality Issues, leading to a more streamlined quality review process. When a QC Specialist corrects specific errors on document metadata, Vault creates and resolves a Quality Issue outlined by the different Self-Evident Correction records.
Self-Evident Correction configurations generate Quality Issues of a defined QC Issue Type based on a document’s lifecycle state and the document fields a user modifies. Vault flags these Quality Issues as Self-Evident Corrections through the SEC Issue (sec_issue__v) field on the Quality Issue object. Self-Evident Correction configurations trigger Vault to generate Quality Issues of the Pre-Approval Issue and Post-Approval Issue object types, based on the related document’s lifecycle state.
Vault only creates one Self-Evident Correction Quality Issue when users change more than one document field defined under the same Self-Evident Correction configuration record. Vault will not create a new Self-Evident Correction Quality Issue if a user changes a document field defined under a Self-Evident Correction with the same Quality Issue Type as an open Quality Issue.
Vault provides two standard Self-Evident Correction configurations: SEC Metadata Correction (sec_metadata_correction_v) and SEC Misfiled (sec_misclassified_v). These Self-Evident Corrections are inactive in Vault by default. An admin must activate these Self-Evident Corrections configurations to allow their use in your vault.
Additionally, an Admin can configure new Self-Evident Correction records to generate additional Self-Evident Correction Quality Issues.
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.