Before you work with this feature

Reproduce a randomization list by copying the same design parameters and adding the same randomization seed number when randomizing multiple lists to ensure the resulting list will be the same as the first.

When reproducing a randomization list with a seed, it's crucial to know that Oracle Clinical One Platform will use and maintain 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.

Details for sponsor users

If you need to duplicate a randomization list for auditing purposes, this is what you should know:

When re-generating a randomization list, on the Randomization tab, a new field called Randomization Seed is available in the Randomization List dialog.

When adding the same seed number and maintaining the same design parameters as the original randomization list, an algorithm can produce a second list as a duplicate of the first. This approach ensures both lists follow the same randomization sequence, maintaining consistency between them.

The process provides proof for regulatory agencies that the study is randomized properly and that the list can be regenerated on request.

More information and step-by-step instructions can be found in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Impact on reports

The following reports will show the randomization seed lists generated under the field of Randomization List:

• About the randomization list duplication
• Generate a randomization list
• Study Design report
• Randomization List (Blinded) report
• Randomization List (Unblinded) report