未承認医療機器を用いた臨床研究実施の手引き
Contents
1.2.
3. 3
4. 1
5. 3 2 2 P 8 30 1 7
6. 3 14 1 14 9 19 D 2 5 14 9 19 2 1
7. 2 3 2 3 2008 4
8. 28 3 3 1
9. 0331 7 0331 7 1 3
10. TH ETH 17 ON E 5
11. W9
12. EU H22 0331 7 Q amp A H23
13. 6 ISO 14155 2011
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15. 3 1 6
16. H22 0331 7 2
17. 14 4 1 1 2 Rm 1 1 E FE E
18. E 18 1 5
19. 12 13 E 7
20. CRF Case Report Form SOP 7
21. 5 II et ey Al A2 B C1 C2 Al A2 MRI CT B C1 MSA C2
22. ny 2 4 E ga 1 3 NRE 1
23. Y 1 1 T
24. 13 E 4 1 4 2
25. 7 7 1 2 3 4 5
26. i 80 3 15 10 NPO
27. 4 27
28. 22 6 18 22 11 30 en 2 Sl Eh 4 METIS
29. 4
30. 0 1 HT F RSet 1
31. EH BT ES 8 Q amp A H23 0331 7 2 24 3 2 1 9
32. OS oe 1 IL II IV WF
33. 19 5 VRH Ll SK
34. TEC60601 1 2 1 1 3 1 ns UE
35. 9 We 10 a 4 ff 11
36. 12 2
37. UMIN http www umin ac jp ctr7index htm http wwwr chmicaltrials p user cte_main Sp https dbcentre3 jmacctmed or jp jmactr 10 9 Q amp A H23 0331 7 9 10 1 3
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40. 14
41. 21 6
42. 8 9 IE 10 20
43. 2 2 No2 3 3
44. 23 2 1 23 2 4 4 2 2 2
45. 21 5 22 23 H22 0331 7 Q amp A H23 0331 7 22
46. H22 0331 7 2011 3 Q amp A i 0 4 METIS 2 7 3 31 1 2 Q amp A H23
47. 6 7 8 H22 0331 7 Q amp A H23 0331 7 23 4
48. 17 13 18 19 2
49. 2 3 4 5 6 7 Ne E 11 E
50. CRE Case Report Form 1 E f
51. 30 4 RR bb V 1 t
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55. X CT MRI E2 EU Global Harm EU onizat ion Task Force 1993 9 2002 2 4 E I E IV
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57. 4 METIS 0 2001 3 NHN 1 2009 10 2012 m 3 http77www jfmda grjjp metis index mim 20 http www jfmda gr jp 4 3 4 900 1984 2 2 2 1
58. YU J 1 10 3 3 1 1 f 1 2 3 4 5 EH BT EH ms 6 f
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60. METTS DD 4 7 31 2009 lt S 2010 3 0331 31
61. 15 4 2 2 2 12 13
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63. 29
64. gt 3 4 1 4 4 i IEC60601 1 E ES ISO10993 1 1 3
65. Ee i 5 EE 3 8 E 6 1 3 Do
66. 29 S0 nn 29 ne ne 29 NSR 30 80 i 30 3 UN 30 4 UE 31 4 METIS 32 7 3 3 17 5 20
67. CRF Case Report Form 18 KU 21 6 CE NO 21 00 21 SR RC CE de SYS 21 ASA 23 23 CO 24 DE BA 6 ET Oe TT 24 EDUJADPyES CCP 24 a 25 D2 DT 25 25 2 LM SSR EE 26 3 05 nn 3 27 NH 0 OS NE 27 Qi SE 27 27 ie kk 27 BB 2 ani 28 9 a8 28 33 ti TE i i 29 1 0 29 2 i 29 3
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71. 2011 9 32
72. 3 EH H22 0331 7 METIS 2 We
73. E 0 E H22 0331 7 Q amp A H28 0331 7
74. Q amp A H23 0331 7 E E SOP Standard Operating Q amp A H23 0331 7 Procedure
75. Rh Q amp A H23 26 0331 7 2 3
76. ONE 8 9 a a 10 11 12 13
77. 0331 7 GCP mM
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