Transcription of 第2回METIS資料 - jfmda.gr.jp
1 5 WG WG2008 4 23 2 2 1. 2. 3. 4. 5. IRB IRB 6. 7. 8. 3 4 2008 3 10 CRO Alquest 3 11 FDA CDRH 3 12 3 13 5 45 CFR46 45 CFR46 NIH NIH IRB 21 CFR PUBLIC LAW 110-85(2007 9 27 )
2 NIH Grant 6 DHHS OHRP Office for Human Research Protections IRB NIH)20 NIH 75% NIH 45 CFR46 FDA) 21 CFR Department of Health and Human Services IRB Institutional Review BoardIRB Audit Grant 45 CFR46 Grant7 Sponsor IRB NSR or SR) IRB FDA NSR or SR) FDA IRB NSR FDA IRB ) IRB SR (Significant Risk )
3 NSR (Non-Significant Risk SRNSRSR 45 46 21 CFR50 56 812 NSR IRB SR Cleveland Clinic SR FDA IDE 510(k) CRO NSR IRB NSR8 Cleveland Clinic Cornell Columbia 2,500 1,000 528 IRB 1,800 2,000 1,500 1,600 1,000 IRB Review $2,000 $500 $2,000 25% 20%NIH Sponsor 45 5530 7040 60 IRB 1 2 IRB 1 1 IDB 35 40 50 2 IRB 1 7 10 8 10 2 IRB 15 16 13 18 8 15 IRB 7 30%33% 3 500 2.)
4 500 NIH Grant 52 48 2008/1 9 IRB IRB IRB WEB IRB 2 IRB 15 90 * IRB IRB Cleveland Clinic IRB 2008/1 10 IRB Cornell IRB IRB IRB IRB IRB IRB IRB 45 CFR46 21 CFR50.
5 56 IRB IRB FDA IDE NIH Grant NIH DB IRB/FWA 40 27 33 2008/1 11 IRB NIH OHRP E 2008/1 IRB IRB 12 PI FDA NIH 90 16 52 CRC 73% 13% 71% 21% 69% 31% 69% 31% 67% 19% 2008/1 13
6 NIH NIH ( ) 30 33 52 18 2008/1 14 NIH 2006 R 37789 / 4334 2008 T F
7 410 2674 47181 100 / NIH 2 JST NIH R P K T&F 15 IRB OHRP IRB NIH OHRP E ) IRB IRB IRB DB ) METIS 5 WG
