Creating a Submission Issue

You can create issues related to a submission project.

Required access roles: Regulatory Lead or submission project owner

For more information about working with issues, see Collaboration and Approvals User's Guide: Issues.

Before you begin: Open the submission project.
Note: You can also create an issue from the list of issues for all apps.
  1. In the navigation pane, click Collaboration.
  2. Click the Issues & Risks page tab.
  3. Click the Issues subtab.
  4. From the page Actions menu or toolbar, click Create Issue .
  5. Enter these details:

    Field NameDescription
    Type

    1. Click .

    2. Expand the tree, and select Submission Issue.

    3. Click Done.

    Choosing Submission Issue adds fields to the issue specific to submissions (the generic Issue form applies to any type of object).

    DescriptionDetails about the problem.
    Reported AgainstShows the name of the context Submission and cannot be changed. If you started from the Issues page for all apps, click to select the needed Submission project.
    Escalation RequiredChoose Yes or No.
    Estimated StartThe date on which resolution of the issue begins.
    Estimated FinishThe date on which the issue is expected to be resolved.
    PriorityChoose a priority level:
    • Low
    • Pre-assigned
    • Medium
    • High
    • Urgent
    Co-ownersClick to choose people responsible for the issue.
    Problem TypeChoose an option:
    • Not Determined
    • 3rd Party
    • Defect
    • Ease of Use
    • Functionality
    • Licensing
    • Installation
    • Mistake
    • Performance
    • Platform
    • Training
    • Usage Model
    Resolution RecommendationEnter the resolution for this issue, if known.
    Steps To ReproduceEnter the steps needed to recreate this issue.
    Category/ClassificationClick to choose from a pre-defined category; click Done.
    Reporting OrganizationBy default, shows your company name. If you need to change it, click to search for the needed organization; click Submit.
    PolicyShows as Issue; you cannot change the policy unless your company has developed additional policies.
    NotesAdd additional information about the problem.
    Received DateClick to enter the date the issue was reported.
    Response Due DateClick to enter the date a response is scheduled to be sent.
    Response Sent DateClick to enter the date a response to the issue was sent.

  6. Click Done.

You can view the issue on this page, or on the Issues page accessed from the Collaboration and Approvals app that lists all issues of all types that you have access to.