1. Clinical Trial Management System Guide
  2. Randomizing Clinical Subjects

Randomizing Clinical Subjects

This topic describes how to randomize a subject for a randomized clinical trial.

To randomize a clinical subject

  1. Navigate to the Site Management screen, then the Protocol Site List view.

  2. In the Protocol Site list, drill down on the site number field of the site for which you want to randomize a subject.

  3. Navigate to the Subjects view.

  4. In the Subjects list, drill down on the screening number field of the subject to randomize.

    The Visits view of the Subjects screen appears.

  5. Complete the necessary fields as shown in the following table.

    Field

    Comments

    Random ID

    Type the ID number assigned to the subject for the randomized trial.

    Randomized Date

    Select the date that you randomize the subject into an arm of the trial.

  6. Save the record.

    The Subject record automatically updates as follows:

    • A Randomized status record is added to the Subject Status MVG (multi value group), and the value in the Randomized Date field is copied to the Date field of the Subject Status MVG.

    • The Status field is updated to Randomized.