Learn how to configure the Safety Reporting Rule Engine to consider blinded clinical trial Cases when reporting to an Agency.
About the Feature
With the 25R3 release, the Safety Reporting Rule Engine supports the ability to determine agency reportability for blinded clinical trial Cases. This feature helps satisfy regulatory requirements for health authorities where blinded Serious Adverse Event reporting is required.
After you have configured this feature, see Manage Organizations for more information.
Update the Organization Layout
Add the Blinded Product Selection field to the Details section of the Agency Detail Page Layout.