In clinical research, timely notifications about adverse events are critical for monitoring patient safety and study progress. With EasyMedStat’s Monitoring Automation feature, you can automatically receive notifications whenever an adverse event is declared. Follow this guide to set up and customize these notifications.

Please note that the example below may apply to any variable, not just adverse events. So you can program notifications based on any variable changing.

Step-by-Step Guide

1. Access the Monitoring Automation Feature

• Open the Monitoring menu.
• From the submenu, select Automations.

2. Create a New Automation

• Click on the "+ New Automation" button to begin setting up your notification.

If no automations exist yet, you will see a message prompting you to create your first automation.

3. Define the Trigger: Variable Change

• Choose "When the value of a variable changes" as the trigger for the automation.
• In the case of adverse events, select the relevant variable that tracks adverse events (e.g., "Adverse Event Declaration"). This will trigger the automation every time an adverse event is reported in the study.

4. Set the Condition

• Click on "+ Add condition"
• Add a condition stating that the "Adverse Event" value is "Yes"

• You can add additional conditions to further refine when the automation is triggered. 
• For example, you might want to trigger the notification only when the declared adverse event is severe. In this case, the condition could be: "Adverse Event Severity" = "Severe"

Conditions allow you to focus on specific types of adverse events, ensuring you're only notified about the most critical situations.

Important Clarification: Conditions and Trigger Timing in Automations

When setting up an automation in EasyMedStat, it's crucial to understand how conditions are evaluated in relation to the trigger. The condition you set must already have a value at the time the trigger occurs, or it will not be verified.

For example:

If your eCRF is designed so that the variable "Adverse Event" (Yes/No) is filled out before the variable "Adverse Event Severity", and your automation is triggered by the "Adverse Event" variable, you should not use "Adverse Event Severity" as a condition.

Why?

At the time the "Adverse Event" trigger is activated, the "Adverse Event Severity" variable may not have been filled out yet. As a result, the condition would not be met, and the automation will fail to execute as expected.

To ensure your automation works properly:

Only use conditions where the variable is already populated at the time the trigger occurs.

This ensures that all conditions can be verified when the trigger fires, preventing any errors in your automation workflow. 

5. Set the Action: Send an Email

• Click on "+ Add action"
• Configure the email (see details below)

6. Configure Email Details

• Recipients: In the Send email to field, search for and select the EMS users who should receive the notification. These users must have access to the series. You can select multiple recipients to ensure key members of the research team are informed.
• Subject: Define the subject of the email (e.g., "Adverse Event Declared in Study XXX"). The subject should contain at least one non-space character.
• Message: Customize the message to include key details about the adverse event. You can use variables to pull in relevant data automatically, such as:
  • Adverse Event Information: Type, severity, date of occurrence.
  • Patient Information: Patient ID, form link.
  • User Information: Name of the user who declared the adverse event.

To insert variables into the message, type “/” to open the variable picker and select the appropriate ones.

7. Save and Activate the Automation

Once you have configured the email details and conditions, activate the automation by clicking on the toggle button.

Ensure the automation is activated (green toggle)). By default, new automations are inactive, so you must activate it for it to start working.

Once activated, the automation will send notifications based on the conditions you’ve set whenever an adverse event is declared.