Form rules allow you to make forms required or unavailable (hidden) depending on whether a different (parent) form has been completed and/or how the fields on this parent form have been answered.
Form rules can be added by clicking the Add a rule link. When adding a form rule, you need to specify the type of rule, which indicates whether the form needs to be either required or not available if certain conditions on the parent form are met. When you set the form to be required, it will show as overdue when the conditions you define are met. On the contrary, if you set it to be not available, it will be hidden when the conditions are met.
Next, select the parent form from the dropdown menu showing all forms in the CRF. Optionally you can enter a reason that will be shown in reports when the condition is matched. This can be helpful during the study to remind you of why certain forms are required or unavailable for a participant.
The Condition section defines the rule. First, select whether the condition applies when the parent form is completed or not completed. This is the simplest type of rule and may be all you need. It means that the current form (that this rule is being applied to) will be required or not available when the parent form is either completed or not completed. So, for instance, you may want to make the randomisation form required once a consent form has been completed. You may also want to hide the randomisation form when the consent form has not been completed. You can add both these rules to the randomisation form separately to achieve this.
Additionally, you can define conditions involving the fields on the parent form. Select the match type to indicate whether all conditions or any of the conditions that you define need to be met for the rule to be triggered. Then, choose the relevant field on the parent form from the dropdown menu and click on Add Rule to add the conditions for each field. You can click on Add Group if you want to define a group of conditions.
In the example below, a rule is being added to a pregnancy form. It will not be available if the parent form (Demographics) has not been completed, or if the field 'Gender' on the Demographics form is not entered as female (i.e. it is entered as male or is empty).
In the following example, we want a blood pressure form to be shown for females aged over 40 and for males on antihypertensives. The form will be hidden if the parent form (Demographics) has not been completed or depending on how the following 3 questions on the Demographics form are answered:
Q1: Gender (Male/Female)
Q2: Is participant over 40 years old? (Yes/No)
Q3: Is participant on antihypertensives? (Yes/No)
The form will be hidden if ANY of the following conditions are met (because match type is ANY):
- Gender is empty
- Gender is Female AND participant over 40 is not equal to Yes (match type is ALL within the group)
- Gender is Male AND participant on antihypertensives is not equal to Yes (match type is ALL within the group)
Display of form rules
Once defined, form rules are shown under the form description. Additionally, any field on the parent form on which a form rule is based shows this information under the field description.