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E3 Structure and Content of Clinical Study Reports

E3 Structure and Content of Clinical Study Reports Question and Answers Document E3 E3 IWG E3 IWG Q A 2 PMDA E3 IWG E3 E3 IWG E3 IWG Q A 3 E3 Clinical Study report : CSR CSR 1996 Q&A 4 E3 5 14. 1. 2. 15. 3. 16. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. E3 - - 6 E3 - - 7 E3 Content and Structure E3 CSR sponsor Appendices E3 E3 Trial Master File (TMF) (ICH E6)

E3:Structure and Content of Clinical Study Reports (治験の総括報告書の構成と内容に関する ガイドライン) Question and Answers Document

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Transcription of E3 Structure and Content of Clinical Study Reports

1 E3 Structure and Content of Clinical Study Reports Question and Answers Document E3 E3 IWG E3 IWG Q A 2 PMDA E3 IWG E3 E3 IWG E3 IWG Q A 3 E3 Clinical Study report : CSR CSR 1996 Q&A 4 E3 5 14. 1. 2. 15. 3. 16. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. E3 - - 6 E3 - - 7 E3 Content and Structure E3 CSR sponsor Appendices E3 E3 Trial Master File (TMF) (ICH E6) Common Technical Document CTD ICH M4)

2 Terminology ICH E3 1995 Step4 1996 8 E3 IWG Q A 2011 4 E3 Concept Paper ICH Steering Committee 2011 6 11-16 E3 IWG reviewer MHLW FDA EMA sponsor JPMA PhRMA EFPIA Canada EFTA 2011 9 2012 5 e-mail 2012 6 2-7 ICH Step 4 sign off 6 21 ICH 9 E3 E3 IWG E3 IWG Q A 10 E3 IWG 1 Content and Structure 2 Appendices 3 Terminology 11 1 Content and Structure Q A E3 E3 PK/PD QOL CSR E3 M4 12 2 Appendices Q A 13 3 Terminology Q A E3 E3 14 E3 E3 IWG E3 IWG Q A 15 Q A 7 Q A 1 Content and Structure Q A#1 #2 2 Appendices Q A#3 3 Terminology Q A#5 #6 #7 Q A#4 eCTD 16 1 Content and Structure Q A Q #1 E3 E3 PK/PD QOL E3 17 1 Content and Structure Q A A #1 E3 E3 18 1 Content and Structure Q A Q #2 E3 3 M4E 10 A #2 E3 M4E M4E CTD CSR 19 2 Appendices Q A Q #3 (16.)

3 Appendix E3 ICH-GCP Trial Master File TMF TMF TMF ICH-GCP 16 7 22 0722014 16 10 18 20 2 Appendices Q A A #3 CSR TMF TMF TMF ICH-GCP 21 3 Terminology Q A Q #5 A #5 22 3 Terminology Q A Q #6 E3 A #6 E3 23 3 Terminology Q A Q #7 protocol deviation important protocol deviation protocol violation ( E3 deviation violation E3 important protocol deviation 24 3 Terminology Q A #7 protocol deviation)

4 Important protocol deviation protocol deviation protocol violation E3 IVa protocol deviation protocol violation important protocol deviation IVa protocol violation protocol deviation important protocol deviation 25 26 3 Terminology Q A IVa eCTD Q A Q #4 E3 PK eCTD 27 eCTD Q A #4 E3 1) eCTD eCTD 2) Study tagging files STF valid values list file-tag file-tag file-tag Study - report -body file-tag 28.

5 ECTD PK 29 PK 12345 CSR 67890 CSR STF PK Study ID = 12345 Study ID = 67890 67890 PK PK file-tag Valid values list 30 BACK UP 31 E3 9. - 32 E3 11. - - 33 E3 12. 34


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