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Coding medical history as ICSRs



  • Irina
    17/08/2015 10:56
    Hi All, Is anywhere mentioned the need to code ICSRs resulting from medical history data? For example we get a report on drug A with reaction A and as medical history we are mentioned reaction B to drug B. Do we need to process two cases, for drug A and drug B respectively, or is it sufficient to capture reaction B to drug B in medical history for case A only? Thanks!
  • GPvP Committee
    02/11/2015 16:54
    This would be a medical judgment that should be made by the medically trained reporter and evaluator. Basically information pertinent to understanding the case would be needed and, if applicable, MedDRA terms should be used in the main descriptive column for disease/surgical procedure/etc. Please refer to the guidance: Maintenance Of The ICH Guideline On Clinical Safety Data Management: Data Elements For Transmission Of Individual Case Safety Reports E2B(R2) and Guidance for Industry E2B(M): Data Elements for Transmission of Individual Case Safety Reports – Questions and Answers.
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