3.人體試驗委員會 嘉南
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- 1. IRB ,
2. ,Clinical Trial
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96 7 17 0960223088 5. IRB/EC Subject protection Autonomy Beneficence Justice Informed consent Good clinical practice 6. 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
7. IRB
- (Institutional Review Board, EthicsCommittee )
8. -- 9. ( )
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JIRB IRB IRB 10. ( ) IRB 11.
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21. IRB 22.
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30. DOH96.6.6
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31. DOH96.6.6
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33. 34. 35.
36. 37. (SAE)
- (Serious Adverse Event) SAE
- SAE
38. (SAE)
- 15 7
- (SUSAR, suspect unexpected severe adverse reaction)
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- monitor
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- sponsor, CRO
- audit
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- IRB,third party
- inspection
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- regulatory authority
44. audit 45. JIRB http://www.jirb.org.tw 46.
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47. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]