Requirement Actions
The system will display the available actions for each requirement based upon the requirement’s status when the user clicks on the action tab to the left of the requirement.
The complete list of actions are displayed and defined in the following table.
|
Action/NextDocs/TMF Health Operation |
Rules | Function/Description |
|---|---|---|
| Action Menu | ||
| Add | Available for all Statuses | Redirects the user to the Smart Document UI in SharePoint with the corresponding Domain/Group and Artifact (Country and/or trial site if applicable) selected |
| Check Out |
Available for all Statuses except Missing, Final and Waived Not available for a requirement whose corresponding document has been checked out in SharePoint |
Checks the document out in the corresponding SharePoint Trial Master File library Adds a “Check Out” icon to the document
|
| Check In |
Not available for a requirement whose corresponding document is not checked out in SharePoint Not available for a requirement whose corresponding document is checked out in SharePoint to another user |
Presents a Check In modal for the user to enter required Comments and select the Check In Type (Minor, Overwrite) |
| Waive | Available for requirements that have a status of “Missing” |
Presents a Waive Item modal for the user to enter a required Reason Sets the requirement status to “Waived” Removes the requirement from the grid view, can be retrieved by viewing all requirements Recorded in the Item Event History |
| View Details | Available for all Statuses | Displays the Item Details in a popup modal |
| View History | Available for all Statuses | Displays the history of all actions performed on the requirement itself, not on the document. This does not duplicate the document audit log |
| Open Document | Available for all Statuses except Missing and Waived | Downloads the document from SharePoint for editing |
| Open Containing Folder | Available for all Statuses except Missing and Waived | Redirects the user to the corresponding document’s location in the SharePoint TMF |
| Undo Waive | Available for requirements with a status of Waived |
Presents a Undo Waive Item modal for the user to enter a required Reason Sets the requirement status to “Missing” Recorded in the Item Event History |
| NextDocs | ||
| Change Lifecycle Status | Available for requirements with a Draft status |
Redirects the user to the Start Workflow page for the corresponding document in SharePoint to transition the document to the next lifecycle stage. If the document is checked out in SharePoint, the system will display a warning that the operation is not available If the review workflow is running on the document, the display a warning that a workflow is already running on the document when the user clicks “Start Workflow” |
| View Audit Log | Available for all statuses except Missing and Waived | Redirects the user to the corresponding document’s Audit Log in SharePoint |
| Copy Smart Document | Available for all statuses except Missing and Waived | Redirects the user to the Smart Document UI in SharePoint with the corresponding Domain/Group/Artifact and Additional Document Information selected |
| Move/Reclassify Smart Document | Not available for requirements with a status of Final, Missing or Waived |
Redirects the user to the Smart Document UI in SharePoint with the corresponding Domain/Group/Artifact and Additional Document Information selected If the document has an active workflow, the system will display a warning that the document cannot be moved |
| Access Workflow Details and Actions | Available for all statuses except Missing and Waived |
Redirects the user to the Workflow Overview page for the corresponding document in SharePoint Displays the Start New Workflow button if the user has sufficient permissions to start a workflow |
| TMF Health | ||
| Reconciled with Paper | Available for all statuses except Missing and Waived |
Presents a Paper Reconciliation modal for the user to select Yes or No and enter a required Location and optional Comment Recorded in the Item Event History |
| Reconciled at Site | Only available for requirements in the Site Documents Container that do not have a status of Missing or Waived |
Presents a Reconcile modal for the user to select Yes or No and enter an optional Comment Recorded in the Item Event History |
| Quality Review | Only available for requirements with a status of Final |
Presents a Quality Review modal for the user to select “TMF Reviewed” or “Issue Identified” and enter an optional Comment Recorded in the Item Event History |
