What is my workflow for setting up a rollover study?

Your workflow as a study team member in a rollover study is the same with your workflow in the original study.

See the workflow to Operate a clinical study in Oracle Clinical One Platform.

1. To get ready for Testing mode, you have to Set up facilities and Define settings. At a minimum, you will have to:
   1. Add and activate depots.
   2. Add sites.
   3. Add regions.
   4. Specify subject, visit, limit, and cohort settings.
   5. Specify supply settings.
   6. Create a resupply strategy and blinded groups of kits.
2. After that,Manage randomization and supplies. At a minimum, you will have to:
   1. Generate or Upload a randomization list and kit list.
   2. Manage expiration dates with lots, and assign kits to manufacturing lots.
   3. Create label groups.
3. Moving on, you can make the rollover study live in Testing mode. Make sure you:
   1. Assign a study version to a site.
   2. Select a resupply strategy for the site.
   3. Open and close a cohort.
   4. Activate the sites.
   5. Release kits to sites or depots.
4. Verify the rollover study.
5. You have to repeat some of these steps to configure your study in production mode. Only then will you be able to make the rollover study live in production mode.

Learn more about how to work during the study conduct period.

Use our Quick Start for the Study Team to have a checklist at handy for setting up your rollover study.