Link forms and connect data across visits

Study designers can now link two or more forms in a study and site users can connect data in these forms to easily track and report data.

What are the benefits?

This new feature allows study designers and site users to connect forms across various visits and easily link together related data. For instance, study designers can link the Adverse Events form to the Concomitant Medications form and site users can then link data in these forms to record which medications were taken because of a particular adverse event or to indicate if an adverse event is related to a medication. This allows sponsor and site users to view subject data in a larger context, easily track and report related data, and achieve accurate results.

Details for study designers

When you create or edit a form you can now add a Link & Show Form rule to a question with radio buttons to associate it with one or more forms in the study. For instance, in the Concomitant Medications form you can add a Link & Show Form rule to the question "Is this medication related to an adverse event?" to connect this form to the Adverse Events form. When the subject answers "Yes", the Adverse Event form is displayed and the site user is able to link the data entered in the Concomitant Medications form to a specific adverse event in the Adverse Events form.

You can add multiple Link & Show Form rules to the same question with radio buttons in the form. Moreover, a form can contain multiple Link & Show Form rules on various questions. And you can also link forms that are included in different visits.

Figure 17-1 How a study designer can associate data on forms

Details for site users

You can now link the information collected from subjects on different forms and visits. If the association was set in study design, you will now notice that when you answer a certain question in a form a new form appears in the same window. In the new form, you can then select the record or records that relate to the data you entered in the original form. For instance, when you add data about a new adverse event in the Adverse Event Form and you enter "Yes" to the question assessing if the subject is taking any concomitant medication, the Concomitant Medications form appears in the same window. In that form, you can select the medication that relates to the adverse event you just added in the Adverse Event form.

A form can be linked to one or more forms, so multiple forms can be displayed in the same window for you to link related data.

Figure 17-2 How a site user can associate data on forms

Already working in a live study?

Once the upgrade is complete, a study designer can start linking new forms in the study. After the updated study version is moved to the Approved container, site users can start linking these new forms when collecting data.