MFDS E2B(R3) updates

Summary

MFDS E2B(R3) IG and Business Rules - Revisions after May 2021 (Enhancements 33560277, 33635071)

Description

The MFDS E2B(R3) profile has been enhanced to include the following updates:

• The business rules published on Aug 04, 2021 and Sep 15, 2021
• The implementation guide published on Jul 7, 2021

The Clinical Reference Type standard and flexible codelists are enhanced to add the CT Plan Number value that is used to transmit the Sponsor Study Number.

For an updated list of mappings and validations for MFDS E2B(R3), refer to eTRM ArgusInterchange84_E2B (R3) Export Mappings.xlsx.