Clinical Data Managers and Programmers can leverage OpenClinica 4’s Insight module to automatically receive alerts for Serious Adverse Events (SAEs). Insight provides powerful reporting and alerting capabilities – for example, it can notify safety officers by email whenever a new SAE is reported.

Overview 

In Insight, you will create a report (question) that identifies SAEs. Then you will define an notification rule that automatically checks this report on a schedule and sends an email notification if any new SAE appears in the data. Typically, the report is configured such that it returns no results under normal conditions – it only returns results when a new SAE is present. This way, the alert triggers only when needed.

This guide will walk you through configuring an SAE report in Insight and setting up alert rules, with step-by-step instructions and screenshots.

Prerequisites 

  • Enable the Insight Module: Ensure that the Insight module is activated for your study. Insight must be enabled to create reports and alerts.
    1. Click on the Settings button within the Study Card on the My Studies page and select the Modules option.
    2. Click the Request Access button in the Insight Module Card to notify the Client Services Team that you are interested in this module.

  • User Access: You should have access to your study’s Insight Reports. In OpenClinica, navigate to your study and click on the Insight Reports section (usually found in the study navigation bar). This will open the Insight reporting interface where you can build queries (called Questions) and dashboards.

Configuring the SAE Insight Report

The first step is to create an Insight report that will capture the relevant SAE data. We want a report that lists new Serious Adverse Events in the study. You can create this using the Insight Question Builder (point-and-click interface) or by writing an SQL query (if you need more advanced logic). Below are the general steps:

  1. Start a New Question: In the Insight interface, click on Ask a Question (or New Question).

  2. Select Your Study’s Data Source: Select Raw Data to select the dataset (study name) and table (form) that includes the Adverse Event data. The exact name of the dataset or table will vary based on the study and form definition. 
  3. Select Fields to Include: Configure the question to retrieve any key fields needed for an SAE alert by clicking on the arrow next to the selected table. Note that many columns in this table will correspond to items in the form definition (e.g. Seriousness), and their names in Insight will be specific to your study build, not with the examples below. For instance, include columns such as: 
    • Site (if applicable) 
    • Participant ID (subject identifier for the event) 
    • AE Number (if multiple AEs per participant) 
      • Note: If this value is not pulled into the form as an item, you can select Study Event Repeat Key
    • Adverse Event Term (description of the event) 
    • Seriousness – this is the critical flag indicating an SAE       
    • Any other AE related fields that you want to see in the report, such as start / end dates, outcome, severity, etc. 
  4. Add Timestamp Data to Filter for Events Entered within a Certain Timeframe: Use the Join feature to add data from the Audit Log to your report so that you can pull in the timestamp for data entry in order to identify which events are new. This helps the alert focus on new SAEs rather than all historical SAEs. For a weekly alert, you might filter to events entered in the last week; for a daily alert, filter to events from the last 24 hours, etc. (You can adjust this based on how frequently you plan to run the alert.)
    1. Click the Join icon
    2. Select Audit Log Events                                                                                               
    3. Select Fields to include. You will need the fields you need from that table, as well as the fields that will allow you to join the Form table and the Audit Log Events table. For instance, include columns such as:
      1. Audit Log Timestamp – The field you need in order to report on only AEs marked serious within the specified period of time.
      2. Study Event Repeat Key and Participant ID – The fields you will need in order to join the data from the two tables.
    4. Select the fields from the AE and Audit Log Events Tables that will be matched in order to join the two tables. Select the field from the first table in the first box, and the field from the second table in the second box. Repeat the process for any other fields that need to be matched up. In this example, the best option will be to select both Participant ID = Participant ID, and Event CRF ID = Event CRF ID.
  5. Apply Filters: In order to avoid extraneous information being included in the report, apply filters:
    1. Report Only SAEs: In the filter section, select the item on the form that indicates whether the adverse event is serious. In the “Enter some text” box, add the applicable choice name. This ensures only serious adverse events (SAEs) will appear in the report.
    2. Report Only One Row Per SAE: Collapse the adverse event table, and expand the Audit Log Event table. Select Audit Entity Key for the AE Seriousness item. Because the Audit Log Event table contains entries for every item on the form, this filter will limit the reported results to just one line entry per SAE.
    3. Report Only SAEs Updated in the Last 24 Hours: With the Audit Log Event table expanded, select Audit Timestamp. Choose Yesterday. When you click on the filter again, you will have additional options to narrow down the timeframe during which the SAEs must be reported. Select the number of minutes, hours, days, weeks, months, quarters, or years, as well as whether there is a certain starting time, or if the results set should include the current hour. Note a filter of “Yesterday” will return results from the preceding calendar day. For results from the preceding day-long period, use a filter of Past 24 Hours.
    4. Additional filters (optional): If needed, add additional filters to narrow down to new or relevant events.     
  2. Preview the Question Results: Run the query to make sure it’s returning the expected columns and filtering correctly. Initially, if no recent SAEs meet the criteria, you may see “No results!” – this is expected (and even desired) if you’ve filtered for only new occurrences, or no SAEs have been entered.
  3. Save the Report: Give the Insight question a clear name and save it in an appropriate Insight collection for your study.

Creating and Customizing the Notification Rule

With the SAE report in place, you can set up the notification so that users are notified when the report returns a result (i.e., when a new SAE is logged). The recommended approach is to add the question to a dashboard and set up a subscription (email notification) for that dashboard so that you can set it so that notifications are only sent when there is data in the report. In our example, we can create a dashboard (e.g., “SAE Alerts Dashboard”), add the SAE report question to it, and then use the Email this dashboard option to configure the notification.

For this guide, we’ll outline the steps using the dashboard subscription method:

  1. Create a Dashboard: From the Insight question, create a new dashboard with a clear name.  Save the dashboard.
  2. Open Subscription Settings: On the dashboard screen, find the email/alert icon or menu. Click “Email this dashboard” (this opens the notification configuration panel on the right side of the screen).
  3. Configure Your Notifications in the Email this Dashboard Panel:
    1. Specify who should receive the SAE notification emails. You can add any Insight user or any email addresses to the To: field. For example, add safety team members, data managers, or other stakeholders. 
      1. Note: All recipients will receive the same content regardless of their permissions in OpenClinica. Ensure that the recipients list is appropriate and does not include anyone who shouldn’t see SAE data.
    2. Set how often Insight should check for new SAEs in the Sent field. For instance, choose Hourly if you want to be notified within an hour of an SAE being entered, or Daily if a daily summary is sufficient. In our scenario, we select “Hourly” for near-real-time notifications. You can also trigger an immediate test by clicking “Send email now” (useful to ensure the setup is working).
    3. Select “Don’t send if there aren’t results” if you only want a notification when there are new SAEs reported. This setting makes the notification conditional on the presence of data (so you aren’t spammed with empty reports).
    4. If desired, toggle Attach results to include the data as an attachment. You can choose a file format (CSV or XLSX). Attaching the results can be convenient so that the email contains the SAE details in a spreadsheet. In our example, we enable attachments and choose CSV or XLSX as needed.
    5. Double-check the configuration and then click Done. The subscription/notification is now active. Insight will now automatically run the SAE report on the set schedule and email the specified recipients whenever the condition is met (i.e., the report has any rows).
  4. Test Your Notification (Optional): You can do this by creating a dummy SAE in a test environment or using the “Send email now” button in the subscription panel to trigger an immediate email. Verify that the email is received and that the content (or attachment) matches the report. This confirms everything is working. If no email comes through, double-check spam folders and ensure that the email integration for Insight is configured properly (SMTP settings in OpenClinica).

 

Using and Managing the Subscription / Notifications After Setup

Once the alert is configured, it will run automatically. Here’s how to use and maintain it:

  • Email Notifications: When a new SAE is entered into the database (for example, a site user marks an adverse event as serious), the next scheduled check will find this in the SAE report. An email will be sent to all recipients you listed. The email will typically include the dashboard name in the subject and the results either in the email body or as an attachment. This allows real-time awareness of critical events.
  • Example – Viewing the Report Data: The SAE Insight report we created will show the details of any serious adverse events that triggered the notification. You can always go into Insight and view this report or dashboard directly to see the list of SAEs. 
  • Editing or Disabling Alerts: You can modify the notification rules at any time. If you go back to the Insight dashboard and click the email/alert menu again, you’ll see options to Edit the subscription or Unsubscribe. For instance, you can change the frequency, add/remove recipients, or turn off the notification. Administrators have oversight of all notifications and can also add additional recipients or disable notifications study-wide if needed. Regular users who receive the notification can individually unsubscribe if they no longer wish to receive emails.

By following these steps, you have an automated notification in place for SAEs. Your Insight module will continuously monitor the incoming data and notify the clinical safety team within the specified timeframe whenever a new serious adverse event is recorded. This helps in timely assessment and follow-up on critical safety events without manual monitoring. With OpenClinica 4 Insight, you can similarly set up notifications for other critical data points (protocol deviations, critical lab values, etc.) using this same process, ensuring proactive trial monitoring and quick actions when needed.