47
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

3.人體試驗委員會 嘉南

  • Upload
    netnk

  • View
    475

  • Download
    6

Embed Size (px)

DESCRIPTION

 

Citation preview

  • 1. IRB ,

2. ,Clinical Trial

3.

4.

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. ( )

  • .

JIRB IRB IRB 10. ( ) IRB 11.

12. 3-1

13. 3-2

14. 3-3

15. 1

16. 2

  • ( )

17. 18. 3

19. ( )

20.

  • ( )

21. IRB 22.

23. 4

  • . ?
  • , ?
  • ? ?
  • , ?
  • ?
  • ?

24. 5

  • ( )

25. ( ) 26. ( ) 27.

  • ( )

28. 29.

    • 9666

30. DOH96.6.6

  • ,
  • :

31. DOH96.6.6

  • :

32.

33. 34. 35.

36. 37. (SAE)

  • (Serious Adverse Event) SAE
  • SAE

38. (SAE)

  • 15 7
  • (SUSAR, suspect unexpected severe adverse reaction)

39. 40.

41.

  • 2

42. 43.

  • monitor
    • sponsor, CRO
  • audit
    • IRB,third party
  • inspection
    • regulatory authority

44. audit 45. JIRB http://www.jirb.org.tw 46.

  • :
  • :

47. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]