Issue

Introduction 

Issues are user-created tasks that allow you to note a finding or raise an inquiry for one or more files. A user can create an issue at any stage of a project.  

Multi-file issues (an issue related to multiple outputs or files) are each displayed as a single issue on the Task Manager page. If updates are made to multi-file issues, the update appears in all related locations. For example, if the issue status is changed with a comment, the new status and comment appear in all locations.

How to Create an Issue [Step-by-Step]

1. When you are reviewing a specific file, click on the “+ Issue” button. 

2. Fill out the relevant fields. 
   The following information can be included when creating an issue:
   • Topic – Limit of 100 characters.
   • Description  –Provide details, Use informative keywords. 
   • Assignee – Assign the issue to a specific person. 
     • By default, the system assigns the issue to the file owner. 
     • You can update the assignee at any time. 
     • The assignee will receive a notification email when the issue is created or updated.
   • Category – Select the relevant category from the dropdown menu: General, Data, or Format.
   • Location – Specify the location in the file related to the issue. 
     • You can assign the issue to specific cells. 
     • For files with multiple pages, you can select to apply the issue to specific pages or all pages. 
   • Highlighting - You can highlight specific text in titles and footnotes to pinpoint the issue. You can also paste or upload images (.png or .jpg directly into task comments to provide visual references.
   • File/Table Selection: For files with multiple tables, you can select which specific table(s) the issue applies to, using the dropdown counters.
   • Priority – Set the priority level of the issue. The system default is Medium.
   • Status – Update the status as needed for issue management. Refer to Task Status Management for detailed guidance on status options.
3. Save.

Issues for Non-Uploaded Files

Issues can be created for all file types, including placeholder files defined in the tracker that have not yet been uploaded to the platform (such as external SDTM and ADaM files). These issues function identically to standard issues and appear in the Task Manager and Progress Tracker for complete end-to-end deliverable tracking.

Automated Assignment Alignment 

To maintain workflow consistency, file assignments dictate task ownership. If a file is assigned to a single Production Programmer, all existing and newly generated tasks (Discrepancies and Issues) for that file are automatically assigned to that user."