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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。

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

更新内容は、以下のRevision History v1.4 をご参照ください。

  1. OID修正（一部）
  2. XPath修正（〃）
  3. Not repeatable（〃）
  4. Rejection/ Warning追加・修正

——————————————————————————————————-

·      Content current as of: 06/05/2023

Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

                 <Updated the Specification Document as follows>

Premarketing Safety Reporting

  1. FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file June 2023)

Postmarketing Safety Reporting

  1. 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