About study objects in the study workflow

The study workflow contains:

• Study design—A study design is a container for the structure of a study. Each study has only one study design, which is created automatically when you create a study. The study design study object is accessible only in a study, not in a library.
• Study elements—A study element is a CDISC term for a basic building block of a study. A study element represents a segment of a study and can consist of one or more study events. Study elements are optional

  In the InForm application, a study element is a collection of visits (or, in Central Designer terminology, study events) that are scheduled as a unit. Although you are not required to use them, consider whether you might benefit from the following uses of study elements:

  • If you want to simplify a complex workflow diagram, create a study element and include several study events in it. Your workflow diagram will have more layers but will be easier to navigate. A clinician might be better able to review a simplified workflow to determine if it accurately represents the study protocol.
  • Study elements make it easy to reuse a collection of study events. If you add several study events to a study element and include the study element in a library, you can reuse all of the study events by reusing the study element.
• Study events—A study event is a subject evaluation checkpoint when data is collected. Study events usually correspond to visits, but one visit can span multiple study events. A study event can contain one or more forms.

  A study event can be repeating. A repeating study event corresponds to a repeating visit in the InForm application.