Update a randomization list that ran out of numbers during the study conduct period

You can upload or generate a new randomization list in an approved version of a study without creating a new version of a study. Consider assigning the new list to the study version before the current list runs out of numbers to avoid randomization errors at sites. This procedure also applies to rollover studies.

1. Generate a randomization list or upload a randomization list.

   Note:

   Make sure the randomization numbers and block numbers do not overlap with the previous list.

   • If you uploaded the original randomization list, you must upload a new randomization list.
   • If you generated the randomization list, you must generate a new randomization list.
2. Assign a randomization list to a randomization design and study version.

   Only one randomization list can be associated with a study version at a time.

   If you create the list in the study version that goes live, you can skip this step.