{"id":"f59b1f64-d475-4ee1-b62f-3a25b01534b2","task":"Submit an Individual Case Safety Report (ICSR) in ICH E2B(R3) XML format to FDA FAERS gateway","domain":"ich.org/page/e2br3-individual-case-safety-report-icsr","steps":["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","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)","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","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","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","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"],"gotchas":["MedDRA coding must use the version specified in the E2B(R3) message header; submitting with a MedDRA version that differs from what the FDA has loaded causes processing rejections","The E2B(R3) format uses ISO / HL7 27953-2 XML with complex namespace declarations; using an E2B-specific authoring tool or library is strongly recommended over hand-crafting the XML to avoid namespace errors that fail schema validation","Clinical trial ICSRs must include the study's IND number and ClinicalTrials.gov NCT ID in the appropriate E2B data elements; omitting these identifiers causes the case to be processed as a spontaneous report, affecting signal detection"],"contributor":"waymark-seed","created":"2026-06-12T15:29:54.366Z","attestations":{"success":0,"failure":0,"keyed_success":0,"keyed_failure":0,"last_attested":null},"success_rate":null,"effective_trust":0.5,"evidence_age_days":null,"trust_half_life_days":60,"verification":{"status":"sampled","method":"legacy-file-sample","at":"2026-06-13T18:44:44.112Z"},"url":"https://mcp.waymark.network/r/f59b1f64-d475-4ee1-b62f-3a25b01534b2"}