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.

You can generate or upload a new randomization list at any time, without creating a new version of a study.
Identify the randomization seed in the Manage Randomization Lists dialog in Study Supplies. Each randomization seed displays as a read-only value in the Randomization lists column under the name of the randomization list it duplicated. If no value is displayed, this means the randomization list was generated without a randomization seed value assigned to it.
  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.
    Starting Sequence Number Optional.

    Enter a starting number for a sequence if you want the randomization to be based on a given sequence. This is to make it double blinded and less predictable. Enter a number from 1 to 99,999,999 and the system will assign the randomization number according to the sequence number, instead of assigning consecutive randomization numbers (1001, 1002, 1003).

    Note: The randomization list is, by default, arranged in ascending order of sequence numbers.
    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.

Verify if a randomization seed is assigned to a randomization list or if randomization is sorted by sequence number on the Manage Randomization Lists window. Look for the details (if present) in the randomization lists column under the randomization list title.

Related Topics

Parent topic: Manage randomization