3 Reporting destinations setup
As per the Business rules for E2B(R3) published by MFDS (
), there are five types of case categories. A report for each case category has to be submitted to a different Receiver Identifier. The case types are:
), there are five types of case categories. A report for each case category has to be submitted to a different Receiver Identifier. The case types are:
- KR case (Domestic Post Marketed)
- FR case (Foreign Post Marketed)
- CT case (Clinical Trial Domestic)
- CF case (Clinical Trial Foreign)
- CU case (Compassionate Use)
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.
