Using the Randomization Module
Unmasking: Unmasking (blinding) is no longer supported for any studies.
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 and Stratification.
Availability: CDMS Randomization is a limited feature module designed for Medical Device companies. Study Protocol must be reviewed and approved before Randomization is enabled. We encourage users to look at Veeva RTSM for the full-featured application.
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 IDs 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 rule options available to determine when to trigger Randomization, such as Informed Consent, Strata Variables, Subject Status, or various other combinations. |
| Emergency Unmasking* | Emergency unmasking is available in case 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. |
| Reveal Treatment | With the Reveal Treatment permission, Sites can view treatment without the unmasking permission. You can also choose whether or not a Site with this permission is required to enter login credentials when revealing treatment. |
| Manual Entry of Kit/Device IDs | If configured, Sites can manually enter the Kit/Device that's given to a Subject. |
| Randomization Invalidation | You have the option to invalidate Randomization if it was done in error. Invalidating Randomization causes the corresponding record in the Randomization List to become invalidated. |
| Automatic System Queries | Vault generates automatic system queries if a Strata Variable changes after a subject is randomized. |
*Unmasking is no longer supported for any studies.
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:
- Navigate to Studio > Settings.
- Click Edit.
- Select “Yes” next to Enable Randomization.
- Click Save.