1. (IRB) ,

2.

• • Good Clinical Practice

3.

4. IRB/EC Subject protection Autonomy Beneficence Justice Informed consent Good clinical practice 5.

96 7 17 0960223088 6.

A:

B:

C:

D:

E:

F:

7. ( ) 8. ( )

.

JIRB IRB IRB 9. ( ) 10. 11.

50 550 250

50 3

12.

( )

13.

14.

( )

15.

:1 2 3

16. 1

IRB

17.

4 :

1.( social, economic, physical, legal, psychological)

2.

3.

4.

18. 2

GCP

19. 20. 3

• Ask a good question

• Be scientific

21. Study aim, hypothesis

Ask a good question

• Clinical relevant

• • Unmet medical needs

• Clear

• • Ask your question in one sentence

• • Dont be too ambitious

• Innovative

• • Unanswered questions

• • Review & critical appraisal of literatures

• Answerable

• • Practical methodology

22. Study design

P Participant

I Intervention(E: Exposure)

C Comparison

O Outcome

T Time

23. 4

24. ( )

25.

( )

26. IRB 27. 5

. ?

, ?

? ?

, ?

?

?

28. 6

( )

29. 7

( )

30. DOH96.6.6

,

:

31. DOH96.6.6

:

32. IRB -Ethical Issue (1/3)

Was there really a need for this clinical trial ?

Best active control treatment or placebo group ?

Has the clinical trial eliminated obvious bias anddeception ?

33. IRB -Ethical Issue (2/3)

Are sample size and statistical power adequate to show an effect if present ?

Were patients chances of receiving an active medicine acceptable ?

34. IRB -Ethical Issue (3/3)

What was the safety of patients entering the clinical trial ?

What type of patients should have been entered ?

35.

36. 37. 38.

(GCP3.3)

(GCP3.2.2)

( ) (GCP3.2.3)

(GCP3.2.4)

(GCP3.2.5)

(GCP3.2.6)

39.

( )

, ,

40.

41. 42. (SAE)

(Serious Adverse Event) SAE

SAE

43. (SAE)

15 7

(SUSAR, suspect unexpected severe adverse reaction)

44. 45.

46.

2

47. 48.

monitor

• sponsor, CRO

audit

• IRB,third party

inspection

• regulatory authority

49. audit 50. JIRB http://www.jirb.org.tw 51. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]