Enable FDA E2B(R3) Standard Reporting Rule Version 4

With the 26R1 release, Safety introduces version 4 of the standard FDA ICSR Reporting Rule Set which adds Investigational to Investigational reporting scenarios. This update supports compliance with FDA E2B(R3) cross reporting requirements.

After you have configured this feature, see Cross Reporting for more information.

Update the FDA ICSR Rule Set Active Version

Navigate to Business Admin > Safety Rule Sets > FDA ICSR Reporting Rule Set and select Edit. Set the Active Rule Version to 4, then select Save.