OutcomeLogix hierarchy

A hierarchical relationship exists between the major components of the OutcomeLogix application and affects most actions you perform.

• Study—The highest level. The study contains everything below it.
• Arm—A subgroup of patients. All the patients in a particular study arm are treated in the same manner, and their visits and forms are identical. Branching can occur at the patient level (most common), visit level, and form level. For example, the difference between Arm 1 and Arm 2 might be a visit that is used for Arm 1 but not for Arm 2.
• Patient—Participants in the study; people under a physician's care for a particular disease or condition. The arm determines the visits and forms set up for each patient.
• Visit—A patient evaluation checkpoint during which a set of forms for the visit must be completed. The study defines the number and sequence of visits for a patient or arm. Patients can visit study sites, complete forms through the Call Center, or sign into the study and complete the visit independently.
• Form—One or more forms that must be completed during a visit. These forms might be Electronic Data Capture (EDC), Electronic Patient-Reported Outcome (ePRO), or a combination of forms. The same form can be associated with multiple visits.
• Item—Items within forms where you enter patient data. An item may be a question, measurement (such as temperature), or a control, such as a checkbox, radio button, drop-down list, and so on.
• Repeating section—A group of items within a form that repeats so that patients can enter multiple diagnoses, multiple treatments, and so on.

You can perform actions at each hierarchical level. The actions you perform at a higher level impact the lower levels. For example:

• Locking a patient locks all of the visits and forms for the patient, even though you did not lock the visits and forms individually.
• Locking a visit locks all forms within the visit.
• Locking a form locks all the items and repeating sections within a form.

Note: Signatures are not propagated to other levels of the hierarchy; that is, the signatures at different levels are independent of each other. The audit trail reflects this independence. For more information, see Signatures and the OutcomeLogix object hierarchy.