Randomization FAQs

• How many times can I randomize in a study?
  It depends on whether your study uses cohorts.
• If my randomization list is blocked by site, country, or region, how are blocks assigned?
  Blocks are assigned either automatically or manually, depending on whether you use dynamic or static randomization.
• How are subjects randomized when multiple cohorts are open?
  During randomization, subjects are assigned the first available randomization number associated with an open cohort. This rule is true whether there are one, two, or more cohorts open.
• What is my workflow for setting up a study with multiple periods?
  You have to perform many of the same tasks, regardless of whether a study is blinded, open label, or both.
• What is my workflow for creating a study that uses cohorts?
  
• Can I randomize subjects without dispensing kits to them?
  Yes.
• Can I determine what happens when the next randomization number is associated with a code for a kit type that is not in stock at a site?
  Yes. You must determine this requirement when you create a randomization design, typically after consulting a standard operating procedure (SOP) at your organization.