What is my workflow for designing a rollover study?

Your workflow for designing a rollover study is almost the same as the one for designing any other study in Oracle Clinical One Platform, with one important mention: a rollover study shouldn't contain a screening visit. Subjects enrolled in a rollover study are already screened in the original study, so you can't screen them again in the rollover study.

1. Work with your user administrator to make sure you're added as a study designer in the rollover study that you need to design and where subjects need to be enrolled by site users.
2. In the original study, make sure you add a rollover type of question in the study completion form. The rollover type of question shows up for site users as a drop-down question with typically 2 or 3 options for the answer. If a site user selects Yes as an answer for the rollover question in a form, the subject is automatically enrolled in the rollover study that you defined for that rollover type of question.

   Note:

   It is the original study that must contain the rollover type of question, not the rollover study. The rollover type of question allows site users to enroll subjects from the original study to a rollover study.
3. Open a study's design.
4. Create visits or events in the rollover study. For more information, see Visits and schedules and Visit branches. Remember that a rollover study shouldn't contain a screening visit.
5. Define the visit schedule
6. Create forms. For more information, see Forms.
7. Add questions in each form. For more information on how to create questions, see Question types and settings.
8. Then add your forms to visits. For more information, see Add a form to a visit.
9. Define the treatment arms and randomization.
10. Add the randomization to the visits.
11. Define the kit types.
12. Define the dispensation schedule.
13. When you're ready to test the rollover study's design, make a study version available in Testing mode.. Also, remember that you can always create a new Draft version of the study to update it in Testing mode.
14. If needed, work with your study manager to test, verify, and make the rollover study live in Testing and Production mode. For more information, see What is my workflow for setting up a rollover study?.
15. You can always make any necessary changes during the study conduct period, as well. For more information, see Updates during the study conduct period

Use our Quick Start for Study Designers to have a checklist at handy for designing your rollover study.