New rule for follow-up notifications on data changes

Study designers can now configure rules in form design to send email notifications. These notifications can be sent upon specific response entries and for data changes in choice type questions, with the option to set follow-up notifications.

What are the benefits?

Email notifications are frequently sent to specific sponsor users based on custom JavaScript rules. With this new feature, study designers can additionally set rules to send notifications while designing a form. These rules can generate email notifications based on choice type questions for a specific answer or for changes to a specific question. To follow an initial notification sent based on a specific answer, you can configure follow-up notifications for data changes in multiple selected questions.

Even though these new rules settings are limited, as opposed to custom JavaScript rules, this process makes it easier for study designers to configure important notifications related to choice type questions and makes it possible to monitor data changes and send follow-up notifications upon an initial email. For example, this feature can help in monitoring Adverse Events after they have been identified as serious. After specific data points are updated, the follow-up notifications are sent for any changes in the questions specified by the study designer.

Details for study designers

Here is what is new for you if you want to start including this type of rule in your form:

• When creating or editing a form, upon selecting a question, you now see a new type of rule that you can configure for that question. This new rule is called Send Notification.
• There are two conditions available to generate a notification. If you select Is, then you must specify the answer of the selected question that generates the notification. If you select Changes, an email notification will be sent every time the answer to that specific question is updated.
• If you choose to send an initial notification for a specific answer (using Is option), you can activate Notify when response changes to the selected questions and then select the questions that, when modified, will send follow-up notifications after the initial email.
• A link to Specify recipients and messages will open a dialog window where you can set user roles and email addresses or distribution lists as recipients, as well as the subject line and body message of the notification and follow-up notifications, when applicable.

Details for rule developers

While you can still use custom rules to send notifications to other study team members, you may want to consider working with your study design team to implement these notifications using the built-in functionality when possible. This reduces your need for custom code. However, keep in mind that rules in form design to send notifications can only be based on choice type questions and set for specific answers and data changes. Contrastingly, while in the Rule Editor you can reference any type of question to send notifications in different scenarios, notifications and follow-up notificiations on data changes are not feasible.

In addition, the email notification template has been updated to unify notifications, whether they are configured based on custom JavaScript rules or based on rules in Study Design. Work with your study design team to avoid sending duplicate notifications and make the most out of this feature.

Working with reports?

Data on notification rules in Study Design mode are included in the Rules report.

Already working in a live study?

As soon as this release is available, study designers can begin configuring rules in Study Design mode to send email notifications and follow-up notifications on data changes.

To make your new rules and updates effective, the Draft version must be moved to the appropriate mode container: Testing, or Approved. For step-by-step instructions on how to manage study versions, see Make a study version available in Testing mode and Make a study version available (for Production and Training mode).