Issues and tasks in a PMS study

  • Published by Viedoc System 2021-08-09
  • Print

Introduction

The Selection page (see Selection page) displays all subjects from all sites you have access to. Each subject is represented by a subject card.

In the top right corner of each subject card, orange and red icons are displayed when there are issues (such as queries) and tasks to be solved/completed for that subject. These icons help you identify where actions are needed.

  • Red icon: Issues - indicating that the subject has open queries and/or unconfirmed missing data. Both open queries and unconfirmed missing data should be handled and resolved by the site but, as a Monitor or Data Manager, it is important for you to be aware of these issues as well. For more details see Queries overview.
  • Orange icon: Task - indicating the number of tasks to be completed for this subject, such as approving query answers, perform reviews, and so on. The orange icons are only displayed on the sponsor side.

Issues

It is possible to switch between the Cards view and Issues view by clicking the Cards icon or Issues icon next to the search field.

The Issues view displays only the list of existing issues.

Click any row to open the form where the issue is raised. If you close the form, you will return to this issue list again.

The list of issues can be filtered by using the drop-down lists on the top right side of the page. You can filter the issues:

  • By site - select to view data from a specific site or from all sites.
  • By issue type/status:
    • All issues
    • All open issues
    • All queries
    • Open queries
    • Queries awaiting approval
    • My queries (default)
    • Pre-queries
    • Missing data
    • Form upgrade pending

Tasks

Note! Task icons are only displayed on the sponsor side.

When a booklet or Adverse Event (AE) report has been received, the orange task icon appears indicating that there is data ready for review, or query answers to be approved. The number of tasks is displayed. If there are more than 9 tasks to be performed on a booklet or form, +9 is displayed in the icon. Tasks should be handled continuously throughout the study to make sure data at all times is as clean and accurate as possible.

Tasks are tracked on three levels:

  • Subject (as displayed on the subject card on the Selection page)
  • Booklet (see image below)
  • Form (see image below)

As soon as a task has been completed, it will disappear from the views.