Schedule for a Submission Project

The Schedule page for a submission project includes the columns and actions for projects, plus columns and actions specifically designed for submissions. The submission project includes the same Schedule page so you can define the schedule in a template, and then reuse that schedule for all new submission projects. For more information about the columns and actions, see Project Management User's Guide : Working With Work Breakdown Structure (WBS).

  1. Open the required submission project. See Opening a Submission.
  2. In the navigation pane, click Schedule.
  3. View the Schedule page tab.

This topic describes:

This page discusses:

Columns

See Timeline for a Regulatory Calendar Page for a list of schedule items for the regulatory calendar phase. Those items also show on this page, but the Timeline includes regulatory-specific details not shown on this page.

SectionColumn NameDescription
NameThe automatically-generated name of the item on this row. The first row always shows the submission project. Rows can be expanded to show the regulatory calendar and all milestones and phases.
TypeThe item type: Submission, Task, Phase, Milestone, Gate, Regulatory Calendar, Regulatory Milestone, Interactive Review, or Review Question.
VolumeA Controlled Folder used to organize documents in a dossier in the exported ZIP file.
IdAn integer that represents the task for the purposes of identifying dependencies.
DependencyLists any dependencies defined for the task.
Click to open the list of Reference Documents checked into the item. You can access any files already checked in, and upload additional files. If no files have been checked in yet, click + to check-in the first file.
Icon indicating the current status for this milestone or activity.
If shows on the row, the item is the content for a route.
StateThe current lifecycle state for this item.
The percentage of work that has been done for the task, as estimated by the task assignee.
%
EstimatedDurationThe estimated time for completing the item.
Start DateThe estimated start date for the item.
End DateThe estimated finish date for the item.
ActualDurationThe actual time to complete the item.
Start DateThe actual start date for the item.
End DateThe actual finish date for the item.
OwnerThe person responsible for the item.
Task RequirementWhether the task is Optional or Mandatory.
Project RoleThe project role that is assigned to the task.
WBSThe item's order in the hierarchy. Integers represent top-level items. Second-level items have one decimal, third-level items have two decimals, and so on.
DescriptionAdditional details about the item on this row.

Actions/Toolbar Commands for a Submission Project

These actions and toolbar commands can be used on the Schedule page for a submission project.

Action NameDescriptionFor More Information
Add/Copy WBSAdds or copies another WBS into the current project. Project Management User's Guide : Listing WBS Tasks within a Project or Task
Deliverables ReportOpens an online report of WBS task deliverables.
Duration KeywordsAllows you to view the duration keywords for the project.
Insert Task AboveAdds a task on the same level as the selected task as a sibling task.
Add Subtask BelowAdds a child task to the selected task.
Insert Existing Project AboveInserts a subproject above the selected task/project as a sibling.
Add Existing Project BelowAdds a child subproject to the selected task/project.
Copy WBS To Selected TaskCopies an existing WBS to the selected task.
Assign by Project RoleAssigns work allocation for selected tasks based on project role.
Add/Remove Selected DependencyOpens the Dependencies page where you can define the dependencies (adding, removing, updating).
Mark as DeletedMarks one or more tasks as deleted. Click OK to confirm. These tasks can still be listed using the WBS Deleted Tasks view. This option removes the task from the WBS calculations, but lets members view the task.
Assign SelectedAssigns members to the selected task.
Delete SelectedDeletes the selected tasks. Click OK to confirm. Tasks must be in the Preliminary state. To delete a task from a WBS, you must be a Project Lead, owner, or task owner. Task assignees cannot delete their top level task but can delete subtasks that they create.
Remove ProjectRemoves the selected project from the WBS. Click OK to confirm.
Sync Submission DossierSynchronizes the selected tasks. Synchronizing means that documents added to the deliverables tab for that task are copied to the controlled folder (if not already present in the controlled folder), and that the most recent version of checked-in documents replace any prior versions of those documents in the controlled folder. The Volume column shows the name of the controlled folder.-
Add Regulatory CalendarAdds a regulatory calendar phase beneath the selected item.

The schedule can only contain a single global regulatory calendar.

The schedule inserts the regulatory calendar after the selected item as a first-level child of the submission project (not as a child of the selected item).

The added items include:
  • Regulatory calendar phase with scope=global and escalation level = 0
  • Regulatory milestone for Clock Start
  • Regulatory milestone for Market Authorization
  • Regulatory calendar phase with scope=local and escalation level=0 for each country associated with the submission project

The app defines the dependency for the regulatory calendar as FS from the originally-selected item. Each local regulatory calendar has an FS dependency from the regulatory milestone with Yes for the connection value.

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Add Existing Calendar From TemplateSearches for and adds a regulatory calendar phase as defined by a regulatory calendar template.

You can only add templates defined for the same regulatory context as the submission project.

The items added to the schedule include all the phases and milestones defined in the template, plus a regulatory calendar phase (scope=local and escalation level=0) for each country associated with the submission project.

The schedule inserts the regulatory calendar after the selected item as a first-level child of the submission project (not as a child of the selected item). The app enters FS for the dependency for the regulatory calendar. Each local regulatory calendar has an FS dependency based on the regulatory milestone with Yes for the connection value.

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Actions/Toolbar Commands for a Submission Template

These actions and toolbar commands can be used on the Schedule page for a submission template.

Action NameDescriptionFor More Information
Add/Copy WBSAdds or copies another WBS into the current project. Project Management User's Guide : Listing WBS Tasks within a Project or Task
Duration KeywordsAllows you to view the duration keywords for the project.
Insert Task AboveAdds a task on the same level as the selected task as a sibling task.
Add Subtask BelowAdds a child task to the selected task.
Copy WBS To Selected TaskCopies an existing WBS to the selected task.
Add/Remove Selected DependencyOpens the Dependencies page where you can define the dependencies (adding, removing, updating).
Delete SelectedDeletes the selected tasks. Click OK to confirm. Tasks must be in the Preliminary state. To delete a task from a WBS, you must be a Project Lead, owner, or task owner. Task assignees cannot delete their top level task but can delete subtasks that they create.