Randomization lists and kit lists FAQs

• Guidelines for creating a kit or randomization list
  If you choose to upload a kit or randomization list into the system, there are certain guidelines related to special characters and file formatting that you should keep in mind before performing this task.
• Can I check that the randomization list or kit list generated by Oracle Clinical One Platform matches my requirements?
  Yes. On the last page of the wizard that generates a list, you can export the list to a CSV file.
• Can I test using a randomization list or kit list that Oracle Clinical One Platform generates and then upload a list from a statistician for a production study?
  Yes. You can also provide the generated lists to the statistician to simplify the process of creating the production lists.
• Can Oracle Clinical One Platform generate a kit list for my study?
  Yes. The kit list is scrambled to protect the study blind. You can also upload a kit list from a statistician.
• Can Oracle Clinical One Platform generate a randomization list for my study?
  Yes, or you can upload a randomization list from a statistician.
• How do I specify the size of the blocks in my randomization list to prevent unblinding?
  You specify a multiplier that is used to calculate the number of randomization numbers in each block in the randomization list. Oracle Clinical One Platform adds the numbers in a treatment ratio and multiplies the sum by the multiplier.
• How many randomization lists should I have for a study?
  To prevent potential unblinding, create separate lists for Testing, Production, and Training modes. If a statistician provides only the production list for a study, we recommend that you upload it for use in Production mode and generate lists for use in Testing and Training modes.