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Edit scrambled randomization

In IWRS, you can edit the previously created scrambled randomization if the numbers within are vacant—not occupied by any randomzation scheme.

Important

If the numbers within the scrambled randomization are occupied—assigned to subjects—you cannot edit its details, and the Edit icon edit_pen_01.jpg next to it is disabled.

To edit the scrambled randomization

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. On the page that opens, in the left pane, select the Period subtab.

  3. In the Period List table that appears, locate the period of your interest. Then in the Period Name column, select the value to open the period configurator.

  4. In the period configurator, in the Scrambled Randomization List table, go to the scrambled randomization that you want to update and select Edit edit_pen_01.jpg next to it.

  5. In the Edit dialog that appears, edit the fields as needed. These fields are identical to the ones explained in the table of the Add new scrambled randomization section.

    Updating scrambled randomization
    Figure 1. Updating scrambled randomization

  6. Select save_button_red.png to save the implemented changes.

Upon saving, the scrambled randomization details are updated. You can also track all changes made to the scrambled randomization via its operation history.

In this section:

A set of global randomization numbers within each period of the multiperiod study used to prevent unexpected unblinding.

In IWRS, the scrambled randomization feature is only available for multiperiod studies to mix up the subject randomization numbers in each cohort so that by viewing the randomization number itself user cannot tell to which arm the randomization number belongs.