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Scrambled randomization list

All scrambled randomizations that you have previously created for your study periods in the IWRS application are displayed on the period configuration page, under the Scrambled Randomization List subtab.

Important

All the functionality related to the randomization is very sensitive. Thus, only users with Unblinded access can view and manage the Scrambled Randomization List page.

Each scrambled randomization from the list has a set of attributes explained in the following table.

Scrambled randomization list
Figure 1. Scrambled randomization list

Column

Details

Scrambled Randomization Name

Represents the name of the scrambled randomization.

Period Sample Size

Represents the number of randomization numbers that is equal to or higher than the number of subjects that are expected to be included in the period and randomized.

Random Length

Represents the number of digits of the subject randomization number.

Start Number

Represents the starting number of the subject randomization numbers chain.

# Occupied

Represents how many numbers out of the complete Period Sample Size number are referenced by a randomization scheme. The occupied number cannot be referenced by any other randomization scheme.

# Idle

Represents how many randomization numbers out of the complete Period Sample Size number are still available for composing randomization schemes.

Created Date

Represents the date and time when the scrambled randomization has been created.

The following actions can be applied to the scrambled randomization items you see in Scrambled Randomization List:

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.