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

Duplicate the randomization list by using the same parameters as in the original with the help of the randomization seed that acts as a vector of the initial randomization list. An algorithm will produce a second list as a duplicate of the first. The seed should only be used if you need a copy of the randomization list for reference purpose.

For step-by-step guidelines on how to use the randomization seed to duplicate an existing list, see generate a randomization list.

WARNING:

If you generate a duplicate randomization list by reusing the same seed, you must first disassociate the previous list from the current study version. Otherwise, the system may assign the same randomization numbers and treatment arms to new subjects, resulting in duplicates.

Note:

Oracle Clinical One Platform always uses the most recent active randomization list for subject assignments. To switch to a previous list, manually unassign the current one from the study version. If you need to recreate a randomization list only for reference purposes, ensure the duplicate list is not used in an active study to avoid subject duplication and other operational risks.

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 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.

Parent topic: Manage randomization