Submit an Individual Case Safety Report (ICSR) in ICH E2B(R3) XML format to FDA FAERS gateway

Steps

1. Structure the ICSR message using the HL7 v3 transmission wrapper as specified in the ICH E2B(R3) Implementation Guide (updated July 18, 2025); the root element is MCCI_IN200100UV01 wrapping the PORR_IN049016UV message
2. Populate required E2B(R3) data elements: C.1 (sender/receiver identification), C.2 (case safety report identifiers, senderSafetyReportId, receive date, transmission date), D (patient characteristics), E (reactions/events with MedDRA-coded preferred terms and LLTs), F (results of tests and procedures), G (drug information with WHO Drug Dictionary coded suspect/concomitant medications)
3. Assign the correct reportType: 1 for spontaneous, 2 for study report (clinical trial cases), 3 for other; clinical trial ICSRs require additional fields including the study registration identifier from ClinicalTrials.gov
4. Validate the XML against the E2B(R3) schema and code lists using an E2B validation tool; check codesystem version values in each coded element against the FDA-accepted codesystem versions published in the FAERS submission guide
5. Submit via the FDA ESG (Electronic Submissions Gateway) using the B2B gateway or AS2 protocol; include the message in the correct folder structure per FDA gateway technical specifications
6. For 15-day expedited reports (unexpected serious adverse reactions), confirm the clock starts on the date of first receipt of the case and submit within 15 calendar days; non-expedited periodic reports must follow the IND annual report schedule