About adding dynamic forms in live studies

Dynamically displaying forms across visits in a study allows you to only display forms when it is relevant for a subject. However, you must pay special attention when you need to make an update during the study conduct period.

When it comes to configuring a dynamic form for a live study, things are a bit complex. Before we dive into the list of tasks that you need to perform, you must consider the following use cases:

• When you need to apply an update for the determining question of a dynamic form to a live study version, you need to mark at least one question in the dynamic form as an update that is being applied to the same study version, as well.
• When the determining question of a dynamic form is updated during the study conduct period, you must apply that change to the appropriate live study version, if desired. That way, the update is reflected in the current study version.

• If the determining question is assigned to a regular visit and the dynamic form is assigned to a cycle visit, the determining question applies to all cycles in the study. The study designer can specify the cycle numbers where the dynamic form must be displayed.

  When configuring a Show Form dynamic rule, and you choose the Current & Future Visits/ Events option, the determining question's display can be limited by the presence of the same determining question in a later visit cycle. For example, the question "Does the subject need weekly hematology labs?" is added to the Week 2 visit. A site user answers "Yes" to this question. Because this question is set up as the determining question for the Hematology form at every visit - and the Current & Future Visits/ Events option is selected - if a site user answers the question with No at Week 8, the Hematology form's display is limited. With a positive answer during the Week 2 visit and a negative answer during the Week 8 visit, a site user will only see the Hematology form at weeks 2 to 7, but they will not see the Hematology form from Week 8 on.

• If a static form is made dynamic or a new determining question for a dynamic form is added through advanced study versioning, one of the following things may happen:
  • After you update the determining question of a dynamic form, if the already given answer to this question matches the new criteria in the Show Form rule, the dynamic form remains visible to a site user.
  • After you update the determining question of a dynamic form, if the already given answer to this question no longer matches the new criteria in the Show Form rule, the dynamic form is hidden in the system. If the dynamic form was already completed, the data that a site user collected is not cleared, it is only hidden.
  • After you update the determining question of a dynamic form and the dynamic form becomes hidden, if a site user answers the newly updated question appropriately, the dynamic form is displayed again and it includes the data that was previously collected.
  • Data collected in dynamic forms, whether hidden or not, is displayed in the appropriate reports in the application.

Note:

When an existing static question, form, or visit that includes data, is changed to a dynamic type, and the determining question is set to hide, the new dynamic item will be hidden. If the determining question is updated to the criteria to show the dynamic item, that item appears and the original data is still there.

Here is a list of all of the possible tasks that you must perform:

1. If you wish to update the determining question of a dynamic form, see Update a form during the study conduct period.
2. If you wish to include a brand new form in the study (whether as a parent form or to dynamically display it), see Add a new form to a live study version.
3. Define a Show Form rule
4. Add a form to a visit.