Randomization replacement

Sponsor users can now replace subjects that have been withdrawn from a study with a new subject that is assigned to the same treatment arm.

In certain scenarios, your study design statistician may want to replace a subject that has been withdrawn early in order to maintain the balance of treatment arms. Now, you can perform randomization replacement to replace withdrawn subjects with new subjects that are assigned the same treatment.

Before you work with this feature

User administrators and unblinded sponsor users assigned the new Replace Randomization permission can update a study's settings to allow randomization replacement.

More information on these permissions can be found in the Add Users Guide after the Release Assessment Environment (RAE) upgrade.

Details for sponsor users

As a sponsor user, here is what's new when it comes to your workflow:

• On the Study Settings tab, in the Visit Settings section, the Allow Randomization Replacement option is now available in the Randomization row.

  Note:

  This setting is set to Off by default.

  When you enable this setting, you're prompted with additional selections:

  • Replacement Starting Prefix: This option requires you to add a prefix for the randomization replacement. The prefix increases by an integer of 1 for each replacement.

    Note:

    A maximum number of 9 digits for the prefix is allowed.
  • Set Max Replacements per Randomization Number: This option allows you to specify how many times a randomization number can be replaced. You are then required to add a quantity in the Max Replacements field.
• Enabling the Allow Randomization Replacement setting does not count withdrawn and replaced subjects, including withdrawn subjects that are not replaced, towards the following study totals:
  • Study randomization limits
  • Site randomization limits
  • Study cohort limits
• Blinded users cannot undo withdrawal when the Allow Randomization Replacement setting is selected in order to avoid unblinding. Additionally, undo withdrawal information does not display in the Subject History for a blinded user.
• Once a subject's randomization has been replaced, the option to undo withdrawal is not available for the replaced subject.

• Note:

  Be aware that if a subject is marked for randomization replacement, then a new randomization list is uploaded, that randomization replacement is discarded, and the new randomization list does not contain the replaced randomization number created for that subject.

  Additionally, if a subject is randomized in a list, and a second list is generated with the subject marked for randomization replacement, the new randomization number is included in the original list, even though it is no longer active.

• On the Subjects tab, in the Manage Subject drop-down menu, the new Replace Randomization Number option is available when the Allow Randomization Replacement setting is enabled in the study settings. When Replace Randomization Number is selected for a subject, the subject's status updates to Withdraw / Rand Replaced in the Subjects list, and Replacement Randomization in the Subject History.

  Note:

  Only users with the Replace Randomization permission can perform replacement and view a replaced randomization.

More information on randomization number replacement can be found in the Sponsor and CRO User Guide after the RAE upgrade.

Impact on reports

The following reporting changes are introduced for this feature when the Allow Randomization Replacement setting is selected:

Report	Type of change	Description
Randomization List (Unblinded) report	Modified column data	The Randomization Number column displays the new randomization number after randomization replacement is updated in the Randomization List.
Study Design report	Modified column data	The Setting column indicates that the Allow Randomization Replacement setting is selected, along with details for: Replacement Starting Prefix Max Replacements (if Set Max Replacements per Randomization Number is selected)
Subject Enrollment report	Modified column data	The Randomized Subjects column does not count the number of replaced randomization subjects towards the total number of randomized subjects.
Study Settings report (Visit Settings tab)	Modified column data	The Setting Option column indicates that the Allow Randomization Replacement setting is selected.
Subject Events report	Modified column data	The Event Type indicates if a subject is marked for randomization replacement.

More details can be found in the Reporting Guide after the RAE upgrade.