About the randomization list duplicate

Learn more about duplicating a randomization list.

In the study process, you may encounter a scenario where an exact copy of the randomization list is needed after you first generated it for the first time, such as providing evidence for auditing purposes. To generate the randomization list duplicate on demand you must insert a randomization seed in the original list as a starting point. With that seed number and the same parameters as the original list, the system generates a new list that copies the same randomization design with the same outcome. The result allows you to recreate any randomization list consistently, so regulatory agencies can verify that the study was randomized correctly.

What sponsor users must know

After you first generated a randomization list for a study, you can reproduce the list by adding the same parameters and randomization seed number. From there, the Oracle Clinical One Platform duplicates the list with the help of the randomization seed that acts as a vector of the initial randomization list.

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.

Note:

Every time you generate a randomization list with a seed, Oracle Clinical One Platform associates and maintains the latest active randomization list to re-shuffle the treatment arms in the study. To revert to any previous randomization lists you need to manually unassign the current active list from the study version.

You can identify the Randomization Seed associated to a randomization list in the Manage Randomization Lists dialog. Each randomization seed displays as a read-only value under each list. If no value is displayed, this means the randomization list was generated with a randomization seed value assigned to it.

If you use the Randomization Generator or upload your initial randomization list, the randomization seed number is also not displayed in the Manage Randomization Lists window.