Working with visits and forms

The hierarchical relationship of patients, visits, forms, and items affects the actions you perform during visits and when working with forms.

• A study consists of a set of visits, each involving completion of one or more study-specific forms. Patients in a particular arm of the study have the same visits and forms. The forms appear as a list below their associated visit on the Patient Summary page.
• A visit is a clinic or hospital visit with a patient at the site for evaluation or dosing during the study. A visit can be:
  • Scheduled on a fixed interval (for example, Follow-up Visit Month 1, Month 3, Month 6, Month 9). A scheduled visit can occur one time or can be a repeating visit that occurs multiple times on demand.

    Each instance of a repeating visit contains the same set of forms. By default, the name of each instance of a repeating visit consists of the name of the previous instance incremented by a number that is specified during study design.

    For example, if the base name of the repeating visit is Visit2, the default name of the first follow-up visit is Follow-up. If the visit is scheduled to occur every three months, the increment value is 3. The sequence of repeating visit instances would then be:

    • RV 1 = Follow-up
    • RV 2 = Follow-up 3
    • RV 3 = Follow-up 6
    • RV 4 = Follow-up 9, and so on.
  • Unscheduled to record adverse events, medication record updates, pregnancies, or study discontinuation.
• A form is a page that contains a grouping of items. Electronic Data Capture (EDC) forms are completed based on patient visit data. Patients complete Electronic Patient-Reported Outcome (ePRO) forms themselves on a study website.
  • After you submit a completed form, you progress to the next form or select the next form, depending on how your study was set up.
  • As you complete forms, the OutcomeLogix application tracks your progress and displays status icons.

As described in OutcomeLogix hierarchy, the actions you perform at a higher level of the hierarchy impact the lower levels.

• Patient level applies to all of a patient's visits, forms, and items.
• Visit level applies to all forms and items within a visit.
• Form level applies to all items within a form.

For example, this means that:

• Freezing a patient freezes all visits, forms, and items.
• Freezing a visit freezes all forms and items within the visit.
• Freezing a form freezes all items within a form.
• Freezing an item freezes only that item.

Note: By default, eSignatures are not propagated to other levels of the hierarchy; that is, the signatures at different levels are completely independent of each other. The audit trail reflects this independence.