The Monitoring Automation feature in EasyMedStat allows users to automate key monitoring tasks, such as sending email notifications when specific events occur during a clinical study. It enables real-time communication and enhances oversight for research teams, particularly in multi-site studies.

Key Functionalities

Automated Triggers

Users can define automations that trigger actions when specific events occur in the study database.

The available triggers in the current version are:

• Patient inclusion
  Trigger actions when a new patient is included in the study.
• Variable value changes
  Trigger actions when the value of a variable changes, for example:
  • declaration of an adverse event
  • abnormal laboratory value
  • inconsistent visit date
  • missing mandatory information

Available Actions

Email Notifications

When an automation is triggered, an email can automatically be sent to predefined recipients.

The email content can include:

• Patient-related variables
  (patient identifier, inclusion date, direct link to the patient form, etc.)
• User-related variables
  (details about the user who performed the action)
• System-related variables
  (timestamps, study metadata, etc.)

Real-Time Alerts

Automations can also display contextual alerts directly inside the eCRF during data entry.

Three display modes are available:

• Popup alerts
  Modal alerts requiring user interaction before continuing.
• Side bar alerts
  Persistent contextual notifications displayed in the eCRF side panel.
• Below-variable alerts
  Inline messages displayed directly below the related variable.

These alerts help users identify potential issues immediately during data entry and reduce data inconsistencies before monitoring or data cleaning.

Conditions and Filters

Users can refine automations using conditions based on:

• variable values
• study sites
• patient data
• study events

This allows highly flexible workflows adapted to each study design and monitoring strategy.

Audit Trail and Compliance

All automations are fully logged in the audit trail.

The system records:

• who created or modified an automation
• when an automation was triggered
• which alerts or notifications were displayed
• user actions related to alerts (for example Confirm or Cancel actions)

This ensures full traceability and supports study compliance requirements.

How to use it in practice?

The following articles will help you to use monitoring automations in your study:

• How to Receive an Email Notification When a Patient is Included?
• How to Receive a Notification When an Adverse Event is Declared