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.
4.
5. 3 2 2 P 8 30 1 7
6. 6
7. E 3 Ds 2 29
8. 3 14 1 14 9 19 D 2 5 14 9 19 2 1 23 2
9. 0331 7 0331 7 1 3 H22 0331 7
10. 2 3 2 3 2008 4
11. 3 DNA
12. 28 3 3 1 2 FE
13. LL xx xx xx 2
14. 6 ISO 14155 2011
15. 3 1
16. W9
17. 8 F 1 gt lt NC Er 7 A
18. E 18 1
19. METTS 2001 3 4 METIS 2 E 20 http www jfmda gr jp
20. 2 EU PS H22 0331 7 0331 7
21. 3 lt I 4 2
22. 2 4 E ga 1 3 NRE
23. 2 8 2 OO 2 5
24. 24 OS NA a RN I 2 3
25. 13 E
26. 25 117 2 2 5 3 BE 1 10
27. i 80 3 15 10 NPO 2
28. 2 3 2 3 2 3 2 3 2 3 2 3 2 4 2 1 15
29. Y 1 1 T
30. xx 5 14 3 2 9 13 OO OOO 1
31. 16 10 7 2 2 24 270 3 11 103 2 1
32. GCP ts 1 F Q amp A H23 GCP
33. 1 A 1 21 f 3 16 19 20
34. 4 1 2 3 Wea 1 FT 5
35. 4 27
36. 2 5 PIN 15 2 16
37. 9 We 10 a 4 ff 11
38. 12 2
39. 22 6 18 22 11 30 NN 2 Sl Eh 4 METIS
40. 1 E E H22 0331 7 3 0
41. 8 9 IE 10 20
42. 4
43. 7 8 Q amp A H23 0331 7 H22 0331 7 23 4
44. EH BT ES 8 Q amp A H23 0331 7 2 24 3 2 1 9
45. 11 0 E H22 0331 7 Q amp A H28 0331 7
46. 4 DNA DNA 4 13
47. 1 E ov 2 3 Es NN 1 5 6 2
48. 53 3 25 7 0 117 F E 11 2 2 i
49. 14
50. HH il l 2 3 2 2
51. 10 2 2
52. 2 2 No2 3 3
53. E 1 62 5 25 140 09 H 2 4
54. I 13 2 5 6 13 24 26 29 28 29 1 2 OO O O GO OO O OO
55. 2 16 18 2 4 17 3
56. ul F OO gt 14 OO O 1 OO OOOO 2 OO 3
57. 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
58. 17 13 18 19 A 2
59. i OO A 3 EN 14 1 25 13 973 MES 14
60. EE 1 14 19 011
61. 2 5 15
62. 14 15 2 17 0 18 4 19
63. 2 3 1 gt 1 2 i 3 i 4 gt
64. 20 21 H22 0331 7 Q amp A H23 0331 7 16 E GOP WW
65. 25 2 1 2 3 4
66. CRE Case Report Form 1 E f
67. E C 2 2 CO 8
68. 18 18 20 8
69. 3 4 5 6 7
70. 2 gt 21 0327006 5
71. 1 14 20
72. 1 6 1 tL
73. 17 3 E 1 10 2 3
74. OS oe 1 IL II IV WF
75. OO ul ys A a 9
76. 012 2 oe Tes OO 1 O 0 y f
77. 4 1 5 1 OO OO OO OO OO 15 16
78. Q amp A 71 23 3 31 0331 7 2008 10 WMA 1 14 3 29 13 CODON 1 OO OO OO xxxxxxx xx N A 3
79. 4 1 6 2 3
80. 7 1 2 I 38 3 4 5 I 6
81. TEC60601 1 2 1 1 3 1 ns UE
82. H22 0331 7 2011 3 Q amp A i 0 4 METIS 2 7 3 31 1 2 Q amp A H23
83. 15 4 2 2 2 12 13
84. 5 II DP A1 A2 B C1 C2 A1 A2 MRI CT B C1 A dt C2 2
85. 7 ER h h dk i 1 3 1 4 14 2
86. l 2009 10 2012 3 jp metis index htm1 1 2 llwww jfmda gr E Ls 0 4 900 i 1984 2 2 2 1 gt 3
87. 17 1 2
88. 34 121 34 123 34 125 34 127 60 43 10 83 3 1 3 45 48
89. E2 EU Global Harm EU onizat ion Task Force 1993 9 2002 2 4 E I E IV
90. 7 TH ETH 17 ON E 5
91. 1 201 1 23 9 METIS TreonFataaen el Nea eve enatiame WF et 1 ee ed 1 1 2 Dn de a ae 1 2 2 3 2 il oso EE RE EE RR 3 D9 i Ek 5 8 NRNNSRIRRRRSGIENGS 7 2 4 ti 10 3 11 Bl lB ee 11 C1 EP ITO RR 11 11 kkk 11 002500H0 11 12 SAR RE 12 6 eds Ge ve 12 Rl k 12 2
92. 15 16
93. ONE 8 9 2 a 10 11 12 13
94. Q amp A H23 0331 7 E E SOP Standard Operating Q amp A H23 0331 7 Procedure
95. 5 19 5 VRH a
96. 1 4 3 bs gt 0 2 O 1 2 3 i 1 5 6 7 3
97. OOOOOO xxxxxxx xx N A 4 lt gt ul xx OO
98. 017 11 12 6
99. 6 21 6
100. 20 21 5 22 23 H22 0331 7 Q amp A H23 0331 7 22 7
101. METTS DD 4 7 31 2009 lt S 2010 3 0331 31
102. 4 14 25 8 1 5 2 26 27 3
103. 1 6 O 3 5 21 22 23 22
104. 15 112 2 1 15 118 2 1 SN 9 10 021
105. 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
106. 2011 9 32 1 2
107. 30 4 RR bb Vy 1 t
108. 22 1
109. E Ee i 5 EE 3 8 E 6 1 3
110. CRF Case Report Form 18 i 21 6 CE NO 21 00 21 SR RC CE NS 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 2 nn a 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
111. 7 19 19 20 14 1 2
112. A 5 6 2 3 7 2 2 53 3 25 117 1 1
113. 3 CRF Case Report Form SOP 7
114. 20 2 21 2
115. x 13 2 8 1 gt E 25 EX I E 3 11
116. 1 YU I H 1 10 3 3 1 1 1 2 3 4
117. 4 1 4 2 14 4 1 1 2 Rm 1 1 E FE
118. 8 11 d 3 f 53 3 1 1 2 ka NS bs 1 3 3 12 uk
119. 14 4 2 lt NR 53 3 i
120. 19 4 1 2 1 2 5 1 4 3
121. H22 0331 7 Q amp A H23 0831 7 1 1 2 3 4 11 f Si ij Rh
122. 24 TLCO 12 12 27 230 1 1 2 19 2 3 uu
123. Q amp A H23 26 0331 7 9 3
124. 1 23 2 4 4 2 2 2
125. 23 9 METIS 1 JJ 2 555LT 3 TERTTTRK 4 JJ 5 6 14 3 29 13 _ 15 16 3 JJ 22 20 7 31 23 20 415 Q amp A 48 21 6 12 0612001 GC 2 65 22 3 31 0331 7
126. 4 1 4 4 i IEC60601 1 E ES ISO10993 1 1 3 X CT MRI
127. Do 0 1 HT F 1
128. 4 lt gt 12 13 E
129. 5 ES ES BT EH HH f 6 1 2
130. O xxxxxxx xx N A xx 4 OO O O xxxxxxx xx N A
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