With the standard Quality Issue object, users can track, manage, and report on quality issues via a user action or Self-Evident Corrections on specified document lifecycle states.
Note: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults.
Configuration Overview
- Add the # of Open Issues, # of Closed Issues, and # of Total Issues document fields to document types that need quality issue tracking.
- Add the Create Related Record user action to document lifecycle states where you want quality issues available. Enter an Action Label and select Quality Issue as the Object, and Related Document as the Field to Default.
- Add Read permission for the Quality Issues object on relevant permission sets.
- Optional: Set the Disable Document Requiredness on Quality Issues setting to true to make the Related Document field optional. If selected, when users delete a document referenced by a Quality Issue, Vault allows the deletion and updates the Related Document field to be blank on the Quality Issue.
- Optional: Adjust the Default Value for the Due Date field on the Quality Issue object.
- Optional: Secure the Study and Blinding fields.
- Optional: Activate or configure Self-Evident Corrections to generate Quality Issues.
Note: A one way flag enables the Disable Document Requiredness on Quality setting. You must enable this feature to use the Document Deletion Log. Once you enable the setting, you cannot disable it at a later time.
Securing the Study & Content Fields
You can enable study and blinding security to automatically populate the Study and Content (blinding__v) fields on Quality Issues.
- Navigate to Admin > Settings > Application Settings > Edit. Set the Enable Study and Blinding Security on Quality Issues checkbox and click Save.
- Add the Securing Study and Securing Content fields to the Quality Issue page layout.
- If there are existing Study and Content fields, remove them from the Quality Issue page layout.
Once enabled, you can configure Dynamic Access Control for the Study and Content fields.
Note: Adding field level security to the Study field may prevent users from resolving Quality Issue tasks.
Configuring Self-Evident Corrections
Self-Evident Corrections allow Quality Control (QC) Specialists to correct specific errors on documents while also allowing Vault to track the occurrence of these Quality Issues, leading to more streamlined quality review processes. 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.
To enable a Self-Evident Correction configuration:
- Navigate to Admin > Configuration > Self-Evident Corrections.
- Select a Self-Evident Correction record.
- From the All Action menu, select Edit.
- In the Status drop-down menu, select Active.
- Click Save.
You can create additional custom Self-Evident Correction records in Vault. To create a new Self-Evident Correction record:
- Navigate to Admin > Configuration > Self-Evident Corrections.
- Click Create.
- Enter a Name and Label for the Self-Evident Correction.
- In the Lifecycle State Types field, select the document lifecycle states when Vault can generate Self-Evident Corrections.
- Select a Quality Issue Type for the Self-Evident Correction. This field corresponds to the QC Issue Type (
qc_issue_type__v) on Quality Issues. - In the Document Fields, select the fields that trigger Self-Evident Correction generation when a user modifies them.
- Click Save.
Note: A Self-Evident Correction cannot contain the same document field in the same lifecycle state as another Self-Evident Correction.