3 ICSR E2B Import Approach

The ICSR Import framework is used to import the new HL7 based E2B R3 ICSR reports. The stakeholders who useOracle Argus Safety as their drug safety application use this framework as an importing platform to pull the information from various sources into their safety database and then process it for various regulatory and non-regulatory purposes using Oracle Argus Safety.

The new ICSR E2B R3 import framework validates the ICSR file using XSD validation, and by executing minimum case creation validations. The architecture of the Import framework is designed to import the ICSR file without any data loss. The framework also allows you to extend any custom profile (For more information, refer to the Appendix section).

As described in the Follow-up specific Import features ICSR Mapping Utility section, the framework provides flexibility to the user to map the incoming E2B as Follow-up to an existing case. It also allows the user to import Follow-up on a non-E2B compliant case.