Updated ICH E2B(R3) Q&As on ICRs

On 17 January 2023, the updated ICH E2B(R3) Questions & Answers (Q&As) Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. 

In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to assist with the implementation of the E2B(R3) Implementation Guide (published in July 2013) and help facilitate transition from E2B(R2) to E2B(R3). In November 2014, the IWG finalized the first version of (Q&As) to clarify questions and comments for E2B(R3) implementation. The Q&As are periodically updated and the latest Version 2.4 has now been released.

ICH E2B(R3) Data Elements for transmission of ICRs

With Version 2.3 a new Q&A 4.23 has been introduced: For vaccines given according to a schedule of multiple doses, how should the ICSR message capture which dose (sequence number) in the schedule that was given?

Information concerning unsuspected dose schedule should be recorded under "Relevant Past Drug History". When information regarding past doses is unavailable, only the information concerning the suspected dose should be recorded. There are the following three scenarios with the relevant data elements provided in the document:

  • Scenario 1: Patient received two doses of the same or different vaccine(s), the first dose is not suspected and the second dose is suspected.
  • Scenario 2: Patient received two doses of the same vaccine and both doses are suspected.
  • Scenario 3: Patient received two doses of different vaccines and both doses are suspected.

Further information can be found on the ICH E2B(R3) Q&As EWG webpage.

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