3 Reporting Destinations setup

As per the Business rules for E2B(R3) published by MFDS (Business rules for E2B(R3)Business rules for E2B(R3)), the reports have to be submitted to 4 different offices, based on the case data.

Therefore, N.1.4 Batch Receiver Identifier and N.2.r.3 Message Receiver Identifier should have one of the below values:

  • Clinical Trial: MFDS-O-CT (Test environment-MFDS-T-CT)
  • Compassionate Use: MFDS-O-CU (Test environment-MFDS-T-CU)
  • Domestic Post-marketed: MFDS-O-KR (Test environment-MFDS-T-KR)
  • Foreign Post-marketed: MFDS-O-FR (Test environment-MFDS-T-FR)

To achieve this, set up four different Reporting Destinations with Agency Identifiers in Oracle Argus Safety.

EDI Tab