Using the Randomization Module

Randomization provides a way to randomly allocate study treatment, thereby ensuring unbiased data for statistical analysis within and across subject groups. Through the Randomization module, the user can download a Randomization list template, fill in the data, and re-upload the template in order to begin the Randomization process. Users can also easily configure various Randomization settings such as Randomization type, data masking, and stratification.

Refer to the table below for more information about Randomization features.

Feature Highlights

Randomization Types The Randomization tab allows you access to various Randomization types including Simple, Block, Mixed Blocks, Stratified, Stratification with Blocks, and Unequal (unbalanced) Randomization.
Randomization ID Randomization ID's are system-generated and are the same as the Subject ID.
Amendments to Randomization Strata variables can be added or removed after a study has gone live.
Enrollment Size You have the ability to append Randomization Lists to support increased enrollment sizes.
Define Rules when Subjects are Available for Randomization There are multiple options available for how to randomize subjects with rules such as Informed Consent, Strata Variables, Subject Status, or multiple combinations.
Emergency Unmasking Emergency unmasking is available in the event of an Adverse Event.
Email Notifications for Emergency Unmasking You can enable email notifications to be automatically sent if emergency unmasking occurs.
Unmasking Reports Unmasking reports detail when a subject was unmasked and by who.
Treatment Reveal With the Treatment Reveal permission, Sites can view treatment without the unmasking permission.
Manual Entry of Kit/Device IDs If configured, Sites can enter the Kit/Device that's given to a Subject.
Randomization Invalidation You can invalidate Randomization if it was done in error. Invalidating Randomization causes the corresponding record in the Randomization List becomes invalidated.
Automatic System Queries Automatic system queries will be generated if a Strata Variable changes after a subject is randomized.

Configuring Randomization

Randomization must first be enabled at the Vault level by contacting Services.

Once Randomization has been enabled at the Vault level, you can configure the Randomization tab through Studio.

To configure Randomization for your study:

  1. Navigate to Studio > Settings.
  2. Click Edit.
  3. Select “Yes” next to Enable Randomization.
  4. Click Save.