医薬品GCP省令ガイダンス -治験の準備及び管理に関する基準-

1 GCP 27 Feb2016 2. 5 . GCP . - - GCP . - - . 2016 2 27 . 26 11 25 .. GCP 27 Feb2016 3 GCP 27 Feb2016 4.. 2002 2003 GCP .. GCP .. GCP 27 Feb2016 5 GCP 27 Feb2016 6.. GCP.. GCP 27 Feb2016 7 GCP 27 Feb2016 8. GCP .. 1 3 . Sponsor 4 15 .. 16 26 .. IIT : Investigator initiated trial Sponsor-Investigator . 27 34 . 35 41 . 42 49 . ( 50 55 ).. 56 . GCP . GCP . 27 Feb2016. GCP 27 Feb2016 9 GCP 27 Feb2016 10. GCP .. 2013 25 4 4 0404 4 .. 2016 1 22 GCP .. GCP 27 Feb2016 11 GCP 27 Feb2016 12. 15 15 2.. 1 SOP .. Standard Operation Procedure SOP .. SOP .. 1 4 .. GCP 27 Feb2016 13 GCP 27 Feb2016 14. 15 3 15 4.. SOP SOP . SOP .. 1 .. SOP .. etc GCP 27 Feb2016 15 GCP 27 Feb2016 16.. 15 5.

2 25 7 1 .. 1 6 ISO15189 .. 25 7 1 . GCP 27 Feb2016 17 GCP 27 Feb2016 18.. 15 . CLIA Clinical Laboratory Improvement Amendments) .. CAP College of American Pathologists . CAP . Laboratory Accreditation Program LAP .. ISO15189 - .. CAP accreditation 22 2 19 0219 4 .. 24 4 2 0402 1 . GCP 27 Feb2016 19 GCP 27 Feb2016 20.. 15 ICH . S1 . S2 . S3 .. S4 . S5 .. S6 . / S7 .. S8 . S9 .. S10 .. M3 .. 24 10 2 1002 5 .. Q&A . GCP 27 Feb2016 21 GCP 27 Feb2016 22.. 15 4 1 2 15 . 15 GCP 9 3 13 . 2-24 . 15 4 1 1 . 15 3 . 10 . 10-1 10-10 . 15 4 1 10-2 10-11 . 3. 10 10-3 . 9 3 13 . 10-12 . 10-4 10-13 . 10-5 10-14 .. 10-6 10-15 . 5. CRO SMO 10-7 10-16 . 10-8 10-17 . 6. 10-9 . GCP 27 Feb2016 23 GCP 27 Feb2016 24.

3 ICH-GCP 15 .. 6 . ICH 15 4 2 . ICH (1) . (2) . (3) . (4) .. 15 4 2 2(1) (4) . GCP 27 Feb2016 25 GCP 27 Feb2016 26.. 15 ICH .. E4 .. E5 R1 .. E7 . E8 . E9 . E10 . E11 . E14 QT . 15 4 3 3(1) (5) . E15 . E16 .. 17 11 1 1101001 .. GCP 27 Feb2016 27 GCP 27 Feb2016 28. 15 1. Investigator Brochure (IB) 15 .. 11 .. 1 11-3 9 3 13 . 11-3-1 .. IB 11-3-2 . 1 11-3-3 .. 11-3-4 .. 1 11-3-5 ex.. IB .. 1 11-3-6 . 11-3-7 .. 2 . 1 . IB . GCP 27 Feb2016 29 GCP 27 Feb2016 30. ICH-GCP . ICH-GCP .. GCP ICH-GCP .. GCP .. 1 1 .. IRB .. GCP 27 Feb2016 31 GCP 27 Feb2016 32. 15 15 .. *.. * 80 2 2 .. 51 1 . 80 . 2 .. 15 .. 15 13 . 15 32 . GCP 27 Feb2016 33 GCP 27 Feb2016 34.. 15 .. 1.. CRF .. 2.

4 CRF .. 3.. 4.. 5. / . / . 6. / .. GCP 27 Feb2016 35 GCP 27 Feb2016 36. 15 15 . 7. 9.. 32 IRB 1 2(1) . IRB IRB. 26 2 40 1 . 26 10 2 40 2 . 8. 26 10 3 40 2 . 40 3 .. 26 2 6 . IRB 32 .. IRB.. 40 4 .. 45 2 .. 45 4 .. GCP 27 Feb2016 37 GCP 27 Feb2016 38. 15 15 . 10. 13.. 32 1 2 11 .. 11. SOP . 14.. 12. 41. 32 1 2 (6) . 2 . 41 2 .. SDV .. GCP 27 Feb2016 39 GCP 27 Feb2016 40. 15 . 15 .. * .. 12 2 6 .. * CRO SMO . 15 . 11) . GCP 27 Feb2016. GCP 27 Feb2016 41 42. GCP 26 3 .. GMP . ( 26 ).. H17 10 25 .. 26 3 . GCP 27 Feb2016 GCP 27 Feb2016. 43 44. GMP GCP 26 2 .. GMP=Good Manufacturing Practice 1 2 . 1) 1) . 2) 2) . 3) . 3) . 4) . 5) .. GMP . 20 7 9 0709002 . GMP Q&A . 21 7 2.

5 PIC/S GMP . GCP 27 Feb2016. 45 GCP 27 Feb2016 46. GCP 26 2 GCP 26 2 . 5 . 5 . 3 .. 5 . IVRS (Interactive Voice Response System). IWRS Interactive Web Response System .. 4 .. 6 .. 7 . GCP 27 Feb2016 47 GCP 27 Feb2016 48. GCP 26 2 GCP 26 4 .. 2 16 2 . 26 2 7 17 .. 30 . H15/5/15 0515018 .. ).. ( .. ) .. GCP 15 2 . GCP 27 Feb2016 49 GCP 27 Feb2016 50. / .. H24 12 28 GCP .. (GCP 2 16 17 ) .. GCP 15 .. GCP 15 .. GCP 26 . 24 12 28 1228 1 .. GCP 27 Feb2016. 51 GCP 27 Feb2016 52. 26 3 .. GCP 26 5 . CIOMS, .. / .. 15 2 .. 19 .. / 15 5 . CRF / 15 4 .. 26 7 9 .. 15 2 . 26 11 26 4 . 26 12 GCP 19 .. 26 6 .. 15 8 . GCP 27 Feb2016 53 GCP 27 Feb2016 54. GCP 26 6 .. DMC: Data Monitoring Committee.

6 [ ].. 1 .. DMC .. 80 2 6 . DMC .. 2 . 3 15 5 2 .. 25 4 4 0404 1 54 1 2 . GCP 27 Feb2016 55 GCP 27 Feb2016 56. GCP 26 6 2 . Adverse Event . 80 2 6 .. GCP 2 10 . 2 . Adverse Drug Reaction 80 2 6 273 1 .. GCP 2 15 .. Unexpected Adverse Drug Reaction . IB .. * / IB . SOP . ICH E2A H20/10/1 H26/2/26Q&A GCP 20 54 . GCP 27 Feb2016. 57 GCP 27 Feb2016 58. ICH 273 1 .. Q&A 26 2 26 Q&A 26 . GCP 27 Feb2016 59 GCP 27 Feb2016 60. 273 1 273 1 .. GCP 27 Feb2016 61 GCP 27 Feb2016 62. 273 3 . 273 .. H24/12/28 1 . H24/12/28 1228 11 .. DSUR . GCP 27 Feb2016. 63 GCP 27 Feb2016 64. 273 .. (1) (2) .. 4.. 7 1 7 1 .. 15 . 15 . 1 . 1 . 15 . 15 . 1 . 1 .. 1 1 . (2) 4.. 7 .. 1 .. 1 .. 15 1 1 .. 15.

7 1 . 1 .. 1 . 1 .. 2013 8 30 . (3) Q&A . 15 . 15 . GCP 27 Feb2016. 65 GCP 27 Feb2016 66.. 24 12 28 1228 1 DSUR . 25 7 1 0701 21 .. ICH Topic E2F 1.. DSUR DEVELOPMENT SAFETY UPDATE REPORT 2.. 3.. 1 DSUR 4.. 5.. DSUR 60 6.. 7.. 8.. 9.. 16 10.. 11.. 12.. 13.. 14. DSUR DSUR . 15. 1 Up Date . 16.. 16 17.. 26 18.. 19.. 20.. 2013 7 1 Q&A . DSUR . GCP 27 Feb2016 67 GCP 27 Feb2016. 68.. 25 5 15 0515 9 . 25 7 1 0701 21 . ICH website PMDA / . ICH-E2F Expert Working Group DSUR - . - .. Model DSUR .. Non-Commercial Sponsor .. lines/Efficacy/E2F/Examples_DSUR/E2F_Exa mple_non- - - .. 25 GCP . GCP 27 Feb2016. 69 GCP 27 Feb2016. 70. 273 H25 7 1 0701 21 .. 25 5 15 0515 9 . 25 7 1 0701 21.

8 7 .. 1 . !!! . 7 .. 1 .. 15 1 15 1 . 15 1 15 1 .. 1 1 . 15 . 15 .. !!! 80 2 6 .. 7 . 15 .. 15 .. GCP 27 Feb2016. 71 GCP 27 Feb2016 72. GCP 48 2 . GCP 26 6 2 . 80 2 6 .. 2 .. !! .. GCP 20 2 3 .. 80 .. 3 .. GCP 27 Feb2016 73 GCP 27 Feb2016 74.. GCP 26 7 . GCP 26 8 .. GCP 26 9 GCP 15 2 1 . Quality Assurance QA . GCP .. Quality Control QC .. Quality Assurance System .. GCP 27 Feb2016 75 GCP 27 Feb2016. 76. 26 7 .. GCP. (H15/6/12 ).. GCP 2 .. GCP 26 7 .. GCP .. H17/10/25 26 7 1 5 .. 26 7 3 . GCP 27 Feb2016 77 GCP 27 Feb2016 78. GCP 26 7 GCP 26 8 . GCP .. !! .. GCP . SDV .. GCP 27 Feb2016. 79 GCP 27 Feb2016 80.. 25 7 1 .. FDA 2013 8 EMA 11 Final Document .. 26 7 1 5 .. 26 7 3.

9 SDV .. ICH E6 R2 Quality . GCP 27 Feb2016. 81 GCP 27 Feb2016. 82.. Risk Based Monitoring RBM .. RBM .. 4 8 On GCP 2 . Site Monitoring . GCP 26 9 1 1 . 100% SDV Source . Data Verification On Site Monitoring , . GCP .. GCP 26 9 1 2~4 . CAPA .. Plan-Do-Check-Act .. GCP 27 Feb2016 83 GCP 27 Feb2016 84. GCP 26 9 .. GCP !! .. GCP 27 Feb2016 85 GCP 27 Feb2016 86.. (GCP 26 7 5) . (GCP 26 8 2 .. GCP 15 7 6) . GCP 26 9 3 . 15 4 1 10 10-10).. 51 1 10).. 26 7 1 26 9 1 . GCP 31 4 .. 27 GCP . GCP 27 Feb2016. GCP 27 Feb2016 87 88. GCP 26 10 .. GCP .. GCP 24 1 .. IRB . !! .. SOP .. IRB . SOP . GCP 27 Feb2016 89 GCP 27 Feb2016 90. GCP 26 11 ICH-E3 ). 1.. CSR: Clinical Study/Trial Report 2.

10 CTD . 3.. 4.. 5.. 6.. 7.. etc . 8. etc 9.. 10.. 11.. 12.. etc 13.. 8 5 1 335 14.. IRB PI . 15.. Q&A . 24 10 18 16.. etc GCP 27 Feb2016 91 GCP 27 Feb2016 92. (1) (2). ICH-E3 .. (H24 10 18 Q&A).. M4E CTD- .. (GCP 26 11 ). Trial Master File .. ICH-E3 .. CSR .. (2003 ).. GCP 27 Feb2016. GCP 27 Feb2016 93 94. GCP 26 12 101 .. 3 GCP 26 .. GCP 41 .. 25 2 14 . GCP 27 Feb2016 95 GCP 27 Feb2016 96. ICH-GCP .. ICH-GCP ICH-GCP . ICH . 2 ICH .. 2 .. IRB .. IRB . GCP 27 Feb2016 97 GCP 27 Feb2016 98.. 26 3 .. Data Management . EDC ePRO .. IWRS .. 25 7 1 . 18 11 20 . GCP 27 Feb2016. 99.. Question ?.