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Notifications for Serious Adverse Events

Castor's Notification settings allow for the creation of email notifications for specific report types. Often users want to create a notification for serious adverse events or those Adverse Event Reports (AE) where it was indicated that an event may have been related to study participation. The standard notification system only allows a notification on the creation of an AE report and not on specific data that was entered in the report.

To get around this, we will use the "report within a report" in order to create a notification for only those AE reports that are labeled serious.

Create Serious Adverse Event (SAE) Report

Create an SAE Report with a report type "Other". This is in addition to your normal Adverse Event Report. 

The SAE Report will not contain any data. It will only include a remark field providing instruction to the data entry user.

Adverse Event Report

  1. Navigate to your Adverse Event Report in form builder. Add a calculation using if/else logic that will inform us if the selected criteria was chosen. In this example, if "Serious" was selected, or study personnel indicates that the Adverse Event may be related to study participation, then a value of "1" will be returned. You may choose to hide this calculation once you have confirmed that it is working properly. 
  2. Next, insert an Add a Report button and link the button to the SAE Report that you previously created. This button should be dependent on your calculation field being equal to 1. 

Create Notification

In your study settings, you can create a report notification on the SAE Report.

Report Tab

The Reports overview will contain both the Adverse Event Report and the SAE Report. Note that you can filter this list by selecting Adverse Event or SAE Report from the 'Filter by report' drop down.

Please note that this method should only be used to trigger a notification for Serious Adverse Events. You should continue to collect your data in the initial Adverse Event Report to avoid having two reports for the same event.

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  1. Castor Support Team

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