New adaptive randomization schemes

Clinical supply managers can now randomize at a stratum level using six new types of randomization for adaptive cohorts, ensuring a more balanced enrollment.

Details for study designers

As a study designer, when it comes to your workflow, here's what's new for you:

• In a study's draft, on the Create Randomization dialog, additional randomization options are available when you choose an adaptive cohort, letting you decide how the randomization is done at a stratum level:

Randomization type	Description
Central Stratified	Randomization balances at a global or central sequential level, from where the subjects are assigned to the next available stratum level.
Country Blocked Dynamic Stratified	Randomization balances at the country-level, from where a set number of blocks get filled based on the cohorts open and stratum limits met. Every country has at least one or multiple blocks bound to their country and the ability to configure the size of the block.
Country Blocked Fixed Stratified	Randomization balances at the country-level, from where the subjects are assigned to the next pre-allocated slot in each country-stratum block.
Site Blocked Dynamic Stratified	Randomization balances at each site level, from where a set number of blocks get filled based on the cohorts open and stratum limits met. Every country has at least one or multiple blocks bound to their site and the ability to configure the size of the block.
Region Blocked Fixed Stratified	Randomization balances at regional level, from where subjects are assigned to the next pre-allocated slot in the region-stratum block.
Site Blocked Dynamic Stratified	Randomization balances at site level, from where a set number of blocks get filled based on the cohorts open and stratum limits met. Every country has at least one or multiple blocks bound to their site and the ability to configure the size of the block. propagate

• When selecting an adaptive cohort method you will now be able to select a stratified randomization option.
• When uploading a randomization list, when mapping headers, there is a new option in the Mapped To column to map a specific header to Stratum.

Details for clinical supply managers and statisticians

• Users with the existing Edit Study Settings permission can determine the limit of strata allowed for each randomization scheme. In a study's setting, in the Enrollment Settings section, under the Cohort section, the new fields Cap and Notification Percent % are available for each Stratum Group you define.
• On the Supply Settings tab, you can enable or disable a stratum within a cohort, with all strata automatically disabled when the cohort itself is unchecked.
• You can enable or disable a stratum within a cohort, with all strata automatically disabled when the cohort itself is unchecked.
• You can update stratum caps for existing cohorts anytime during the study conduct period, without creating a new study version.
• The randomization lists now include two new columns: Stratum and Cohort.
• In the Generate Randomization List dialog, on the Select Randomization section, you can now choose Number of Blocks from the Length drop-down when using a stratified adaptive randomization design. Enter the block size you want for each treatment arm. The generated randomization list will create a separate list for each stratum, with balance maintained according to your chose strategy - central, regional, or site level, and dynamically or with fixed allocation.
• In the Upload the Randomization List dialog, on the Map Headers section, the Stratum and Number of Blocks fields are now available in the Mapped To drop-down. On the Map Data Point page, you must map both the cohort and stratum fields for the upload to succeed.
• When stratum limits in a cohort group reach the threshold defined in the study settings, a notification is sent.

Impact on notifications

The Randomization update notification now includes information about the stratum limit within a cohort. It displays the percentage at which the notification was set and indicates when the limit of randomized subjects is reached. Once the limit is reached and subject assignment is no longer possible, a notification is sent to contact your Clinical Research Associate.

Impact on reports

Report	Type of change	Description
Study Settings Report, Cohort Limits by Cohort tab	New column	Now includes a Stratum Limit column next to each cohort. Shows "N/A" when displaying Cohort Limit details.
Study Design Report	New row	Now includes a new row about stratum limits, a new table about the Stratum Group design.
Subject Randomization Data Extract	New data points	Now includes details in the existing Stratum field.
Randomization Report (Blinded and Unblinded)	New data points	Now includes details in the existing Stratum field.
Kits and Randomization Design dataset	New data element	The RANDOMIZATION_STRATEGY data element is now included in the Randomization folder. The following randomization types are available: Central Stratified Site Blocked Dynamic Stratified Country Blocked Dynamic Stratified Country Blocked Fixed Stratified Region Blocked Dynamic Stratified Region Blocked Fixed Stratified

More information can be found in the Study Designer User Guide, Sponsor & CRO User Guide, Reporting Guide , Analytics User Guide and Notifications and Permissions Guide after the Release Assessment Environment (RAE) upgrade.