Transcription of E3 Step 5 Questions and Answers - European Medicines …
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E3 Step 5 Questions and Answers - European Medicines …
7 Westferry Circus Canary Wharf London E14 4HB United KingdomTelephone+44 (0)20 7418 8400 Facsimile+44 (0)20 7418 agency of the European Union European Medicines Agency, 2012. Reproduction is authorised provided the source is 2012 EMA/CHMP/ICH/435606/2012 Committee for medicinal products for human use (CHMP)ICH guideline E3 - Questions and Answers (R1)Step 5 Transmission to CHMP for informationJuly 2012 Release for informationJuly 2012E3 - questionsandanswers(R1)EMA/CHMP/ICH/4356 06/2012 Page 2/10E3 - Questions and Answers (R1)1. Content and structureDate of ApprovalQuestionAnswer1 June 2012 Some in the pharmaceutical industry have expressed concern that the ICH E3 Guidance, Structure and Content of Clinical Study Reports (hereafter, E3), is intended as a requirement, a template that must be fact that the M4 guidelines for the CTD refer to specific structural elements described in E3 ( , Clinical Study Report [CSR] section headings) may have contributed to this of E3 as a rigid template can result in presentation of redundant and suboptimal information in CSRs.
in 12.3.1.2 may lead to double or mis-counting of deaths. Can this issue be clarified? 6 June 2012 Section 12.2.2 of the Guideline states that all adverse events occurring after initiation of study treatments should be displayed in summary tables. The example table in Section 12.2.2 of E3 (Adverse Events: Number Observed and Rate, with Subject
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