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- ゆりな さどひら
- 5 years ago
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1
2 1
3 IRB IRB CRC CRC 2000 EDC 2
4 baseline Network draft protocol feasibilitystudy 20 CCR 1 9 timeline 40 coordinating centre Minnesota e-learning seminar 3
5
6 34 4 (1) IMCJ 2500 (2) CRC MRC (3) DM JCRAC DMC (4) Central IRB (5) % 86% PMDA IT 5
7 DM DM CRC IRB IRB IRB IRB 1 / PC FileMaker 1 2 6
8 IRB IRB EMEA CRC3 DM
9 CRC % Translational TMC Medical Center, TMC 8
10 1. (1) H H H17 50 H18 55 H (2) IRB 20 IRB (3) H H H19 56 H20 67 H19 0 H20 5 H H20 68 H19 2 H20 11 / H19 18 H ARO 6 DM11 OJT 24 e ARO (HITCANDIS) 100 TR CRC 3 IRB CRC TV CRC 4. NPO 9
11 NHO GCP NHO NHO CRB NHOCRB NHO CRC NHO NHO EBM 20 26,541 10
12 IRB 14 IRB
13 IRB SOP PMDA CRC 12
14 IRB EC HIV 13 National Lead Investigator Asian Study CRC 8 4 LDM1 5 13
15 IRB EDC CRC 55 JCOGWJOGJGOG 20 CRC3 1 14
16
17
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20 H H H20 21 /195 H H H20 13 / HP ( ) H H H H CRC H19 3 IT H19 H20 H20 EDC medidata RaveI nformeclinical TM IRB DVD H19 2 /14 H20 2 /9 5 /39 H18 1 /10 H19 1 /6H20 2 /35 H H19 10 H20 11
21 , , % 72%65% CRC 202 CRC2 21 PhRMA Duke PMDA FDA MHRA IT IT IRB I RB ( 3,171
22 19 12 ( 20 1 CRC IT learning CRC CRC IRB SDV CRC CRC 1) ) 3) IRB
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24
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27 ) i IRB IRB 2. 4 IRB IRB IRB IRB 5 ii ) i ii % % % % iii. ( ) iv. CRC CRC v CRC 3) % ,163
28 % CRC10 ( 8 2 )CRC 1 ( 1 ) 5 ( 2 3 ) CRC % % IRB IRB CRF CRC 2 (2008 ) CRC 10 (2008 ) CRC2CRC 2 IRB (2008 ) 2 )92%(3) 63%(11 )72%(3 )
29
30 19 () FPI ( ) ( ) H H (17) (81) 3 2 H (2400) (221) IRB SDV 8
31 IRB CRC3 CRC CRC 3 CRC 3 IT 20
32
33 %65.1%68.5% CRC CRC CRC 2 On the Job Training 4 80
34 % % 3 IRB IT 20 ))
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36 2005 CRC IT 3 50% 80% 3 IRB % 76.9% IRB CRC CRC IRB LDM CDM
37 Base Line48,394, ,242, ,145,81.4 BL % IRB 4 IRB CRC WJOG %, 10.9% 49.4%, 2.1% 4.6% CRC( ), CRC() 1 IT CE IT Excel PDF Net Net SDV PDA SDV SDV
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39 ( 最 小 値 )
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41 CRC Web CRC CRC IRB IT HL
42 IT CRF DM 20 IRB CRC 20 5 SoCRA CRC PMDA DM1 1 CRC 21 CRC 1 10 IT IT 3 HL7 e-crf 19 PDF J-STARS
43 IRB FPI IT IRB IRB IRB IRB IRB GCP IRB Web Web IT HL7 CRF e- CRF IRB GCP
44
45
46 IRB FAXRDC LAN CRC
47 3 3 2 HTR 19 CPC GMP HTR 16 GMP (1 ) (1 ) (1 PMDA (2 ) web 172 HTR HTR OJT HTR 3 HTR HTR IT HTR 3 HTR HTR CDISC
48 1 1 2 TRC in CRF TR TR TR 21 2 TR TR IT CRC TRC, CPC CPC OJT OJT TR TR TR
49 1 TR TR TR 1 TR TR TR TR TR TR TR TR CPC CPC GMP cgmp GMP SOP TR TR TR TR TR TR TR 2 12 CD26 3 TR TR
50 SOP DM GMP 20 GMP DDS GMP ER/ES ER/ES GMP GMP 2 Research,, TR
51 TR TR GMP GLP GLP TR 2 CPC GMP GLP TR CPC 11 WT1 HVJ-E IL-6 6
52 GMP Open(TR) TR TR MEDEC CBDMICBMA-CPCTRI IBRI TR GMP TR TR TR TR TR TR 51
53 52
44 4 I (1) ( ) (10 15 ) ( 17 ) ( 3 1 ) (2)
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