Step 6: Create groups of visits (optional)

To create a group of visits in Central Designer, you create an element. It's useful to create elements if your study is randomized and requires multiple treatment arms.

For example, you might create an element that contains the visits and forms for subjects taking a specific drug, and another element that contains the visits and forms for subjects taking a placebo. A randomization rule determines which element a subject progresses to.

To create an element:

1. At the bottom of the Project Explorer, click the Visit Schedule () button.
2. At the top of the Project Explorer, right-click Study Design, and select New Element.
3. Enter a title, RefName, and description, and click OK.
4. In the Project Explorer, select the visit, and click the Properties tab.
5. Next, add visits to your element.
   • To move a visit from the study design to the element, in the Project Explorer, select the visit, and drag and drop it onto the element.
   • To add links or copies of existing visits to the element:

     Tip:

     You might want to do this if you want to use a visit in more than one treatment arm.

     • Click the Add to tab, which appears on the right of the page by default.
     • Optionally, search for a specific visit or filter the list by entering a keyword in the Filter field.
     • Select one visit, or press the Ctrl key and select multiple visits.
     • At the bottom of the tab, from the drop-down list, select:
       • Add as link—Add a link to the visit. If you update the visit object, it is updated in the element.
       • Add with children—Add a copy of the visit and its children. If you update the visit object or its children, they are not updated in the element.
       • Add without children—Add a copy of the visit without its children. If you update the visit object, it is not updated in the element.