Review Questions for the Regulatory Calendar

The Review Questions page tab lists the structure and details for interactive review phases and review questions defined for the submission project.

View lets you choose several views that show or hide columns specific to the purpose of that view. This topic describes the Review Questions view. See Project Management User's Guide | Listing WBS Tasks Within a Project or Task for information about the other available views.

This page tab only shows Interactive Review and Review Question types. To see all tasks and phases of the submission project, view the Schedule page tab.

Required access roles: Regulatory Lead, submission owner, or task assignee

To access this page:

  1. View the Schedule page for the Submission project. See Schedule for a Submission Project.
  2. Click the Regulatory Calendar page tab.
  3. Click the Review Questions page tab.

This topic describes:

This page discusses:

See Also
Defining Review Question Tasks

Columns

SectionColumn NameDescription
NameThe automatically-generated name of the interactive review or review question. Click to view the structure for that specific item in a new window.
TypeThe item type: Interactive Review or Review Question.
#The number that corresponds to the question received from the regulatory authority. Top-level questions use a 1, 2, 3... sequence. The next level uses numbers such as 1.2, 1.3, and so on. You can define the hierarchy based on the questions received from the regulatory authority.
SevThe severity for the interactive review or review question: Low, Medium, or High.
Question TextThe question asked by the regulatory authority.
Answer TextThe answer to the above question.
Click to open the list of reference documents checked into the review question. 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.
VolumeThe controlled folder that contains documents and deliverables related to the task. Click to view the contents of the controlled folder in a new window.
DateReceivedOnly shows a value for interactive review phases. All review questions use the date for the phase they are associated with.
PublishingThe date the interactive review phase was published.
Est FinishThe estimated finish date for the interactive review or review question.
Actual FinishThe actual finish date for the phase or task.
The status of the interactive review or review question:

IconDescription
(blank)The interactive review or review question is not complete but there is more than 5 days remaining before the due date.
The interactive review or review question is complete.


The interactive review or review question is not complete and there are less than 5 days remaining before the due date.
The interactive review or review question is not complete and the current date is after the due date.

%Percent complete value.
StateThe current lifecycle state for the interactive review or review question.


Click to open the list of assignees for the review question. You can view the current assignee, add additional assignees, and remove assignees. If no one has been assigned to the review question in yet, click + to open the Assignees page where you can add assignees.
NotesAny additional notes related to the review question.

Actions/Toolbar Commands

The tools in the Actions and Edit menus, and the quick task creation toolbar, work the same way as the standard WBS page described in the Project Management User's Guide. However, if you add a task to a review question, the task does not show on this page. View the Schedule page to see the new task.

Properties for Interactive Reviews and Review Questions

An interactive review phase and review question are both types of tasks. As such, the Properties page show the same fields as the Properties page for any task plus additional Market Registration-specific fields. An interactive review phase has these additional fields:

  • Needs Review
  • Publishing Date
  • Received

A review question has these additional fields:

  • Needs Review
  • Severity
  • Question Text
  • Answer Text