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.

Tip:

To prevent potential unblinding, create separate lists for each mode. If a statistician provides only the production list for a study, upload it in Production mode and generate lists for Testing and Training modes.

We recommend you first create a randomization list in Testing mode before you create one in Training or Production mode.

Do you want to upload a randomization list, instead of generating one? See Upload a randomization list.

1. Access the study version for a given mode as described in Open the design of a study version.
2. Along the top, click Study Supplies.
3. Below the study name, make sure the Randomizations tab is selected.
4. From the Randomization List drop-down, select Generate.
5. Select the randomization design that you want to generate a randomization list for, and click Next.

   Tip:

   Only the randomization designs that randomize subjects and that are assigned to a visit appear.
6. Fill in the fields, and click Generate.
   To view tips for completing a field, click into the field or choose an option.

   Note:

   You can re-generate an existing randomization list by adding the same design parameters and the same Randomization Seed. For more information, see About the randomization list duplication.

   Option	Description
   Title	Enter a title for your randomization list.
   Description	Enter a description for your randomization list.
   Mode	Choose the mode that the randomization list is available in.
   Multiplier for Blocks	Enter the number used to calculate the size of blocks in the randomization list. The numbers in the treatment ratio are added and multiplied by this number. For example, for a 1:2 ratio, if the multiplier is 4, each block size is 12 (1 + 2 = 3, and 3 x 4 = 12).
   Starting Number:	Enter the first number in the randomization list.
   Length	Enter the length of the randomization list, calculated by the randomization numbers in the list, the number of blocks per strata, or the number of blocks per cohort.
   Randomization Seed	Fill in this field to generate a list for the first time or reuse the seed to generate a second list as a duplicate of the first list. The number you enter must be from 1 to 99,999,999. WARNING: If you skip the seed field and generate a randomization list using the same design, the result will be a new and different randomization list, not a duplicate. Reproduce any randomization list number as long as all parameters match the initial format. For example, if you initially added 1234 in the Randomization Seed field, use the same 1234 number for the Randomization Seed, as well as the same randomization design in the new list you are generating. Caution: Oracle Clinical One Platform will use the most recent active randomization list to re-randomize the treatment arm.

7. Click Finish once you complete the wizard.

We recommend using dynamic block assignments. However, if you are doing static block assignments with a generated randomization list, you must assign blocks of randomization numbers to each site, country, or region. For more details, see Assign blocks of randomization numbers to a site, country, or region.

To view or manage generated randomization lists, the list associated with study version, or the generated Randomization Seed, select Manage from the Randomization List drop-down. The Randomization Seed number is displayed as read only on the Randomization Lists column under the name of the randomization list it duplicated. Revert to the old randomization list by manually unassigning the study version.

You can generate or upload a new randomization list at any time, without creating a new version of a study.