3 Reporting destinations setup

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

Therefore, BATCHMESSAGERECEIVERIDENTIFIER [N.1.4] and MESSAGERECEIVERIDENTIFIER [N.2.r.3] should have one of the below values:

• Domestic Clinical Trial: MFDS-O-CT (Test environment-MFDS-T-CT)
• Foreign Clinical Trial: MFDS-O-CF (Test environment-MFDS-T-CF)
• 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 five different reporting destinations with agency identifiers in Oracle Argus Safety.