Oracle Health Sciences Clinical One Platform

Tutorial for Creating and Managing Visit Branches in an Oncology Study

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Scenario: In this tutorial, you will set up a visit schedule for a simple Oncology study with two treatment arms: Treatment Arm A - Standard of Care and Treatment Arm B - Standard of Care Plus Active Drug. The visit schedule begins with two standard visits, a Screening visit and a Baseline visit. After completing the screening and baseline, the visit schedule continues with two distinct visit branches. These branches are based on the treatment arms used in this study and the visit schedule described in each branch cycles for a total of two years. Once the treatment completes, subjects enter a new branch schedule for a Follow Up visit that cycles every 8 weeks for an indefinite period. The visit schedule concludes with a completion visit.

Note: The study design might also include other types of visits and events, such as Adverse Events or unscheduled visits, but in this tutorial we are focusing on the feature of branching and cycling visit schedules.

Prerequisites: To create and schedule visits branches you must first create a study and define the treatment arms that are used to randomize the subjects. For more details see Create a study and Define a treatment arm.

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