人體試驗委員會 嘉南Handout
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談談談談談談談談談談談談 談談談談談談談談談 : 談談談談談談談談談談談談 談談談談談談談談談 : IRB IRB 魏魏魏 魏魏魏 魏魏魏魏魏魏魏魏魏魏 魏魏魏魏魏魏魏魏魏魏 魏魏魏魏魏魏魏 魏魏魏魏魏魏魏 , , 魏魏魏魏魏魏魏魏 魏魏魏魏魏魏魏魏
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Transcript of 人體試驗委員會 嘉南Handout
- 1. IRB ,
2. IRB
- (Institutional Review Board, EthicsCommittee )
3. The main tasks of the IRB/EC
- WHO guideline
- Toassess the scientific meritsof the research
- To verify that the research is inconformity with the laws and regulation , especially in relation with the protection of human subjects
- To evaluate theethical acceptabilityof the research
4. IRB /
- Regulation
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- Good Clinical Practice
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- Ethics
- Science
5. ,Clinical Trial
6.
96 7 17 0960223088 7. (2005/01/07) Good Clinical Practice GCP
- ICH E6Guidance for Industry E6 Good Clinical Practice
8. (2005/01/07)
- , , ,
9. Helsinki Declaration
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10.
11. -- 12. IRB/EC Subject protection Autonomy Beneficence Justice Informed consent Good clinical practice 13. Whats Science?
- Measurable
- Reproducible
- Comparable
14. 15. ( )
- .
JIRB IRB IRB 16. ( ) IRB 17. ( ) 18. ( ) 19. ( ) 20.
- ( )
21.
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- 9666
22. 23. DOH96.6.6
- ,
- :
24. DOH96.6.6
- :
25.
26. (SAE)
- (Serious Adverse Event) SAE
- SAE
27. (SAE)
- 15 7
- (SUSAR, suspect unexpected severe adverse reaction)
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29.
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30.
- monitor
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- sponsor, CRO
- audit
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- IRB,third party
- inspection
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- regulatory authority
31. audit 32. IRB Monster or Partner? 33. JIRB http://www.jirb.org.tw 34. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]