Manage randomization

Once you are done setting up sites, depots, labs, and other study settings, a clinical supply manager and other sponsor users can begin configuring settings for the randomization processes of a study.

• Define settings for Testing mode first, so you can test and verify a study version using mock data.
• Configure settings for Production mode once you have verified that the study design and settings are working as expected.
• Configure Training mode settings to match those defined for Production mode, so that users who operate your study can get properly trained with the real study configuration using mock data.

• Generate a randomization list
  Create a randomization list for Testing mode when you're ready to test data entry and randomization. Create a randomization list for Production and Training mode when you're ready to make the study live.
• About the randomization list duplicate
  Learn more about duplicating a randomization list.
• Upload a randomization list
  Create a randomization list for Testing mode when you're ready to test data entry and randomization. Create a randomization list for Production and Training mode when you're ready to make the study live.
• Understand the concepts used in minimization
  Minimization can be particularly useful for studies that aim to balance subjects across treatment groups. A key aspect of working this this type of randomization design is understanding the main concepts that it operates with.
• Upload a randomization list for minimization
  Create a randomization list for minimization in Testing mode when you're ready to test data entry and randomization. Create a randomization list for Production and Training mode when you're ready to make the study live.
• Assign blocks of randomization numbers to a site, country, or region
  You must assign blocks of randomization numbers to a site, country, or region if you selected a type of randomization with Fixed in its name, and you either generated a randomization list in Oracle Clinical One Platform or uploaded a randomization list that didn't identify sites, countries, or regions for blocks. This procedure also applies to rollover studies.
• Assign a randomization list to a randomization design and study version
  You typically need to assign a randomization list to a randomization design and study version if you created a second randomization list for a randomization design (such as if you added a treatment arm to a study and needed to create another randomization list to support it). This procedure also applies to rollover studies.