Managing the Question and Answer Phase

You use the Timeline page tab on the Regulatory Calendar tab to define an interactive review phase of the submission process.

You can also add the interactive review phase and review questions on the Schedule page the same way you add any tasks. For more information about creating phases and tasks, see Project Management User's Guide.

Required access role: Regulatory Lead

Note: You must create tasks that are specific to Market Registration, such as Interactive Reviews, Review Questions, or Regulatory Milestones, in the appropriate places in the app. You cannot create a project task, such as a Task, Phase, Gate, or Milestone, then change it to a Market Registration type task.

This task shows you how to:

Before you begin: View the Timeline page tab for a submission project.

Defining an Interactive Review Phase

You can add an interactive review phase, and the accompanying questions, to the Timeline structure.

  1. Select the regulatory milestone that you want to precede the interactive review phase.
  2. Click Actions > Add Interactive Review

The app inserts an interactive review into the timeline.

Defining Review Question Tasks

You need to define the questions received from the regulatory authority. Follow this procedure for each question. The interactive review phase must already be added to the timeline.

You can use the quick task creation toolbar to create multiple questions at the same time, and then add the details directly in the structure. However, you then need to edit each task individually to enter details that do not show in the columns (such as Question and Answer text).

You can use the Review Questions page tab to add the questions (and use the quick task creation toolbar) and enter the required details directly in the structure.

  1. Access the Review Questions page tab for the required submission project. See Review Questions for the Regulatory Calendar.
  2. Click Enable Edit on the page toolbar.
  3. Select the interactive review phase in the list.
  4. From the Type drop-down list, select Review Question.
  5. In the No box, enter the number of questions you want to create.
  6. Click . The app inserts that number of rows with the type set to Review Question.
  7. For each question, enter these details directly into the table:

    Field NameDescription
    SeverityChoose Low, Medium, or High to indicate the importance of the question.
    Question TextEnter the question that this task is responding to.
    Answer TextEnter a brief response for the question. Detailed responses can be provided by adding documents to the Deliverables tab for the review question task.
    VolumeClick to search for and select the Controlled Folder to use for delivering the response documents.
    Est FinishEnter a date by which the review question is estimated to be answered.
    Assignees Click + to add assignees.

    In the Assignees page, click Add Assignee to search for and add people to the list of assignees. You can add any user that has at least the Regulatory User role.

    Select the person most responsible for the review question as the owner, then click Assign as Task Owner.

    You can also use the Assignees page for the task to manage who is responsible for completing this task.

    NotesComments about the review question.

    The table includes other columns that you can edit, however, you likely do not have the information for those columns when you create review questions.

  8. Click Save.