Working with Checklists for Milestones

You create a checklist in the context of the submission project or submission template. You can then copy that checklist to other schedule items in other submission projects as needed. When you create a submission project based on a submission template, all checklists and checklist items included in the template are copied to the submission project.

See the checklist topics in Project Management User's Guide: Working With Gates for more information about checklists and checklist items.

This task shows you how to:

Create Checklists

Before you begin: Required access roles: Submission Lead on the submission project with Regulatory Lead or Regulatory User role, or submission project owner
  1. Access the Schedule page for the submission template or submission project.
  2. Click the name of the milestone or regulatory milestone where you want to add the checklist.
  3. In the navigation pane, click Checklists.
  4. Select the milestone. You can also create a hierarchy of checklists if needed.
  5. In the page Actions menu or toolbar, click Create New Checklist.
  6. Enter a Name and Description for this checklist.
  7. Click Done.
  8. Create the checklist items.

Create Checklist Items

Before you begin: Required access roles: Submission Lead on the submission project with Regulatory Lead or Regulatory User role, or submission project owner
  1. View the Checklists page for a milestone in a submission template or submission project (see above).
  2. Select the required checklist.
  3. In the page Actions menu or toolbar, click Add Checklist Item.
  4. Enter a Name and Description for the item.
  5. Choose the type of response the Regulatory Lead should enter to determine if the item has been completed. You can choose one of these options:

    • Yes | No
    • Make | Buy
    • Approved | Conditionally Approved | Not Approved
    • White | Red | Green | Blue | Yellow

  6. Click Done.

Complete Checklist Items

To complete a milestone or regulatory milestone, all checklist items for all checklists attached to that milestone must have responses entered for them.

Before you begin: Required access roles: Submission project owner with Regulatory Lead role
  1. View the Checklists page for a milestone or regulatory milestone in a submission project.
  2. Click Enable Edit .
  3. In the Response column for each checklist item, select the appropriate response.
  4. Click Save.
    Market Registration enters your name in the Completed By column for each checklist item.

After all checklist items have responses, you can promote the milestone or regulatory milestone to the Complete state.