Transcription of E3 Structure and Content of Clinical Study Reports
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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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