Summary

This article describes the different states that a subject can be in throughout a clinical trial such as “Screened,” “Enrolled” and “Completed.” 

Table of Contents

Design | System

Subject statuses refer to the different states that a subject can be in throughout a clinical trial such as “Screened,” “Enrolled” and “Completed.” With this feature, a subject’s status can be tracked as the subject moves through the clinical trial. The Software Implementation Specialist (SIS) can also configure the status flow to meet the requirements of the trial.

Activation

The Subject Status feature must be activated before it can be used in an existing study. If the Subject Status feature was configured for the study prior to deployment, skip this section.

The activation link must be configured by the Software Implementation Specialist (SIS) before it is available on the study homepage.

Note: The Subject Status feature will only record statuses once it has been activated. This means any historic statuses from before activation will not be accounted for, making the feature less effective when deployed as a mid-study change.


  1. On the study homepage hover the mouse over the ‘Actions’ button and select ‘Activate Subject Status’.
    • An ‘Activate Subject Status’ screen will display the results of the activation and report any errors.
  2. Click the ‘OK’ button to continue.

The study homepage and Subject Manager will now display the status for all enrolled subjects.

Subject Statuses

View Subject Statuses

  1. On the study homepage, review status information in the Subject Status widget.
  2. On the study homepage, click the ‘Subjects’ tab to access the Subject Manager.
  3. View the status for each subject in the Subject Status column.


View and Delete Subject Status History

  1. Navigate to the Subject Manager.
  2. Check the checkbox next to the subject(s) to be viewed.
  3. In the Actions dropdown menu, select ‘View Subject Status History.’
  4. Click the ‘Go’ button.
    • The system will display all information related to the subject’s status history.
  5. Check the checkbox next to the status that should be deleted.
  6. Click the ‘Delete Checked’ button to delete the selected statuses.

View Subject Status History in Standard Reports

  1. On the study homepage, hover the mouse over the ‘Reports’ tab and select ‘Subject Statistics.’
    • The system will display a table of color-coded subject status information. Green text corresponds to the subject’s current status while black text corresponds to past statuses.

View Status Changes in Audits

  1. On the study homepage, hover the mouse over the ‘Audits’ tab and select ‘Subject Audits.’
  2. View the subject status information in the Action column of the Audits table.



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