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FDA (FAERS) : 2023年6月5日(Mon) :FDAは “E2B(R3) Core and Regional Data Elements and Business Rules version-up 1.4” の発出を行いましたFDA: upverion the FDA E2B(R3) Core and Regional Data Elements and Business Rules - Version 1.4.xlsx
お客さま 各位
HiroPharmaConsulting Newsletter Vol. 5 No.6のお知らせです。
2023年6月5日(Mon) :FDAは “E2B(R3) Core and Regional Data Elements and Business Rules version-up 1.4” の発出を行いました。
更新内容は、以下のRevision History v1.4 をご参照ください。
- OID修正(一部)
- XPath修正(〃)
- Not repeatable(〃)
- Rejection/ Warning追加・修正
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· Content current as of: 06/05/2023
Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS
<Updated the Specification Document as follows>
Premarketing Safety Reporting
- FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file June 2023)
Postmarketing Safety Reporting
- FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file June 2023)
Version Number | Version Date | Version Description |
1.0 | Apr-2022 | Initial Version |
1.1 | Jul-2022 | • Reconclied data elements D.2.1, D.2.3, D.9.3, E.i.4, E.i.5, E.i.6a, G.k.2.1.1a, G.k.2.3.r.1, G.k.2.3.r.2b, G.k.3.2, G.k.4.r.3 conformance with ICH IG • Removed the business rule for data element N.2.r.2 stating “ICSR batches with non-approved sender identifiers will be rejected.” • Warning changed to rejection as per ICH IG for data element C.1.9.1.r.1 and C.1.9.1.r.2 • Changed the rejection and warning rule for data element D.1 on postmarket to use nullFlavor “NA” instead of the text “NONE” • D.8.r.2a conformance changed from Conditional-Required to Optional • D.10.6 conformance changed from Optional to Conditional-Required • D.10.8.r.2a conformance changed from Conditional-Required to Optional |
1.2 | Aug-2022 | • Updated Conformance and Business Rule for data element FDA.E.i.3.2h under Pre-Market (IND and IND-exempt BA/BE) • Clarified the Business Rule for data element FDA.G.k.10a.r under Pre-Market (IND and IND-exempt BA/BE) |
1.3 | Jan-2023 | • All data elements specific to vaccine reporting are hidden and must not be used of non-vaccine reporting • All rejection and warning rules for vaccine reporting are hidden and must not be used of non-vaccine reporting of ICSRs • ACK.B.r.7 max length changed from 250 to 2000 • D.1 Pre-market business rule clarified • D.10.8.r.2a max length changed from 20 to 10 to comply with ICH max length • C.2.r.4 conformance changed from Required to Conditional-Required • G.k.1 business rule updated in the tab “Rejection and Warning Rules” • G.k.4.r.9.2b and G.k.4.r.11.2b Observation Code under conformance updated from C42636 to C54456 • G.k.4.r.10.2b Observation Code under conformance updated from C38114 to C54455 • Updated “Rejection and Warning Rules” tab to include error id and error description, if rule is not satisfied • Corrected XPath for the data elements FDA.G.k.10a.r and FDA.D.11.r.1 • FDA.G.k.12.r.3.r max length chnaged from 6 to 7 to accomodate IMDRF Code |
1.4 | Jun-2023 | • Corrected OID value in XPath for data element FDA.G.k.12.r.11.r, FDA.G.k.12.r.10, FDA.G.k.12.r.8, FDA.G.k.12.r.2.r, G.k.4.r.10.2a, G.k.2.1.1a, G.k.2.1.1b, D.8.r.2a, D.8.r.2b, D.10.8.r.2a, D.10.8.r.2b • Corrected XPath for FDA.G.k.12.r.9 • Updated FDA.G.k.10a.r to FDA.G.k.10a and the data field is not repeatable • Updated “Rejection and Warning Rules” tab to shortern the error description • Added warning “W0008” and “W0009” under the “Rejection and Warning Rules” tab • Added rejection “R0100”, “R0101” and “R0102” under the “Rejection and Warning Rules” tab |