Include predefined labels to create tabular forms

Study designers can now add Label items to repeating forms and display data in a tabular format. This helps site users easily enter and compare data.

What are the benefits?

With predefined labels you can design tabular forms. A tabular form allows a site user to better review subject data during a study and offers them a holistic view of subjects' evolution.

As a study designer, Label items let you add predefined, read-only values to a repeating form and better control the data that is collected. By adding predefined labels to your repeating form, you can restrict or expand the number of rows that a site user can use to collect subject information. For example, when you create a Physical Exam form, you can now add a Label item as the first question on the form and title it Body System. You can then specify predefined, read-only values for each body system that is examined (such as, Ears, Nose, Throat). This allows you to define the exact number of rows to be displayed in the form and the items for which you want to collect data. Depending on your needs, you can let site users add additional rows for other body systems or you can limit the data they collect to a fixed number of rows. This gives you more control over the data collection process, reduces the potential for error, and allows for easier data entry.

Details for study designers

On the Data Collection tab, when you create a repeating form you can now:
  • Add a Label item in the form, which serves as the column header for any predefined values
  • Allow site users to add additional rows to a form

Figure 19-5 Study designers can now add a Label type item to a repeating form

Label is the new item type that study designers can add to a repeating forms

Figure 19-6 Study designers can allow site users to add new rows to a repeating form

New toggle button to allow site users to add additional rows to a repeating form

Details for site users

Your workflow for collecting data hasn't changed, but you will notice some design updates if you are completing a tabular form with predefined labels. Here's what's new:
  • Label values are read-only and you can't edit or delete them
  • Depending on the study design, you may be allowed to add extra rows of data in a tabular form. The Add button is only present for forms that allow you to collect extra data rows

Figure 19-7 How site users see Label items in a repeating form

How Label items are displayed in a repeating form

Already working in a live study?

As soon as the upgrade is complete, study designers can create tabular forms with predefined labels. After the study version is moved to the Approved container, site users may encounter tabular forms in new or updated live studies.